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AI · cancer

Намерени 1,748 изпитвания за "cancer" Стр. 53 от 88

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Ablative Therapy of Oligometastatic Tumor After Response to Conventional First Line Treatment

Solid Tumor

Advancements in systemic antineoplastic therapies have led to improved overall survival rates for many solid tumors. However, metastatic disease remains a significant challenge and remains the leading cause of mortality for these patients. Additionally, there is a high attrition rate after first-line standard treatment across various tumor types, with studies indicating that 20-70% of patients may be unable to undergo second-line therapy, depending on the tumor type. This highlights an urgent need to enhance outcomes from the first line of treatment. Although first-line therapy often represents the best available option, most patients experience relapse and disease progression despite an initial tumor response. This is attributed to both intrinsic and acquired resistance arising from the heterogeneity of primary tumors and metastases. To address this issue, metastasis-directed therapy (MDT) has been explored as a way to reduce tumor burden and mitigate the risk of resistance due to therapeutic selective pressure. MDT offers a promising opportunity to improve first-line treatment outcomes, but more precise patient selection criteria are needed to maximize therapeutic benefit and minimize the potential toxicity of ablative therapies. Indeed, despites its efficacy, fatal complication may occur so do grade 3 to 4 toxicities. Toxicity depends of the local ablative therapy (LAT) planned but as it will never be none, oncologists have to propose invasive treatment to patient that may benefit the most. Based on the published data, the investigators propose a pragmatic, selective approach centered on sensitivity to systemic therapy. The investigators aim to evaluate the benefit of local ablative therapy (LAT) in patients who demonstrate non-progressive disease after three months of first-line standard of care. Given the importance of this question across cancer subtypes, the investigators will employ a prospective database to enroll patients with various solid tumor type, excluding the ones for which the impact of LAT has already been explored or may be difficult to achieve. Outcomes of this strategy will be evaluated compared to outcomes from pivotal studies defining optimal standard first line therapy (OST) . Several analyses will be performed to better characterize the population for whom a multimodal approach may significantly improve their survival. The first one will aim to compare the median duration of response (mDOR) of the population treated with LAT compared to the mDOR reported by the pivotal study(ies) of each OST. This study will serve as a proof of concept, supporting chemosensitivity as a viable selection factor for multimodal treatment in a broad range of cancer types. Primary objective: Improvement of the duration of response (DOR) after completion of LAT compared to DOR reported in pivotal study that evaluated first line OST. Secondary objectives: * Evaluation of the safety of the addition of LAT. * Evaluation of overall progression free survival (PFS) and PFS at 1 year. * Evaluation of overall survival from OST start and from the time of LAT completion. * Documentation of acceptance and compliance to LAT decision by the institutional expert committee

Начало: 01.06.2026 Край: 01.06.2036 Възраст: от 18 г.

Belgium, Cyprus, France +2 Chirec NCT07545486

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Pathophysiological Mechanisms Involved in the Pronostic and Evolution of Non-Small Cell Lung Cancer (NSCLC) at All Stages of the Disease

Non Small Cell Lung Cancer

This single-center observational cohort study conducted at Bordeaux University Hospital aims to establish a structured clinico-biological platform in non-small cell lung cancer (NSCLC) to investigate the biological mechanisms involved in tumor initiation, progression, and relapse across all disease stages (I-IV). A total of 150 consecutive adult patients with histologically or cytologically confirmed NSCLC will be included over a 3-year period. Tumor samples will undergo translational analyses. These biological data will be correlated with pseudonymized clinical data collected from medical records and the institutional clinical data warehouse. The primary objective is to characterize the molecular, metabolic, and immune mechanisms associated with tumor progression and recurrence in NSCLC. The central hypothesis is that integrating comprehensive clinical data with in-depth molecular and immunological analyses of tumor tissues will identify biologically distinct patterns associated with disease evolution, therapeutic resistance, and prognosis. Such integrated clinico-biological signatures may improve patient stratification and contribute to the identification of novel biomarkers and therapeutic targets in NSCLC.

Начало: 01.06.2026 Край: 01.06.2041 Възраст: от 18 г.

University Hospital, Bordeaux NCT07470476

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A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer

Breast Cancer

A Multicenter, Observational Study on the Real-World Effectiveness and Safety of inavolisib Combined with Endocrine Therapy With or Without a CDK4/6 Inhibitor in Patients with HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer.

Начало: 16.05.2026 Край: 30.07.2027 Възраст: от 18 г.

xuliang NCT07543250

Предстои набиране Фаза 3

A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

Metastatic Colorectal Cancer

This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluoride/tipiracil (FTD-TPI) plus bevacizumab.

Начало: 05.05.2026 Край: 31.10.2029 Възраст: от 18 г.

Germany, United States EMD Serono Research & Development Institute, Inc. NCT07549412

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Diagnostic Accuracy and Prognostic Value of 18F FDG PET-CT in the Follow up of Patients With Colorectal Carcinoma.

Rectal Cancer (Stage III)

The goal of this observational study is to learn about the diagnostic and prognostic value of 18f fdg pet ct in follow up of colorectal cancer patients The main question it aims to answer is: Does pet ct have a role in treatment decision in colorectal cancer patients? Participants already be undergoing for pet ct as part of their follow up routine and will be followed up for 5 years.

Начало: 01.05.2026 Край: 05.03.2031

Assiut University NCT07536321

Предстои набиране Фаза 3

Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer

Advanced/Metastatic Breast Cancer HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer

This study aims to evaluate whether the combination of Megestrol Acetate at the initiation of Trastuzumab Deruxtecan (T-DXd) treatment can effectively prevent and alleviate T-DXd-related fatigue, thereby improving the quality of life for advanced breast cancer patients.

Начало: 01.05.2026 Край: 01.04.2031 Възраст: 18–75 г.

China Sun Yat-sen University NCT07543536

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Application of 3D Reconstruction for Preoperative Strategy of Locally Advanced Colon Cancer

Colon Neoplasms Locally Advanced Colon Cancer 3D Reconstruction

The aim of this study is to assess the usefulness of a mathematical model of three-dimensional image process and reconstuction (3D-IPR) as a surgical planner in locally advanced colon cancer. In addition to comparing the diagnostic accuracy of this planner with that of the CT regarding the infiltration of neighbouring structures.

Начало: 01.05.2026 Край: 01.05.2031 Възраст: от 18 г.

Fundació d'investigació Sanitària de les Illes Balears NCT07528937

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eQuoL Effectiveness Study

Childhood Cancer Survivors

This prospective cohort study aims to evaluate the implementation and impact of the MyCare eQuoL digital tool across nine clinical sites in Europe: Italy, France, Hungary, Germany, Switzerland, Belgium, Slovenia, Spain, and Norway. MyCare eQuoL is an innovative digital tool designed to support Childhood, Adolescent and Young Adult Cancer Survivors (CAYACSs) in self-assessing their supportive care needs. Based on a built-in needs assessment, the tool provides tailored feedback including relevant information, self-management strategies, digital resources, and links to online support. It also generates a personalized needs summary to facilitate more targeted discussions with healthcare professionals. Feedback is customized through a "content suggestion engine" that is based on personal characteristics (e.g. age, sex, country), on the user's needs assessment, and can consider other data types as well, like the survivors' treatment history, or potential late effects. The primary objective of the study is to assess the effectiveness of MyCare eQuoL in improving patient activation among CAYACSs across diverse European healthcare settings. Eligible participants include males and females aged 16-30 who were diagnosed with cancer before age 25, have completed their treatment at least five years prior, are currently disease-free, and have sufficient digital literacy and language proficiency to engage with the app. Exclusion criteria include severe cognitive impairments or ongoing treatment for recurrent or secondary malignancies. The study follows a structured data collection timeline. At T0, eligible survivors are identified and invited to participate through mail or telephone. Informed consent and contact details are collected from those who agree to participate. At T1, after obtaining consent, each participant is assigned a unique study ID and attends a clinical visit (either in-person or virtual). During this visit, baseline demographic and treatment data are recorded in a secure electronic Case Report Form (eCRF). Participants are then trained to use the MyCare eQuoL app, complete the baseline questionnaires, and receive a personalized Care Plan and, where available, a digital Passport. At T2, six months post-intervention, participants receive automated reminders to complete follow-up assessments, including validated questionnaires evaluating changes in activation, quality of life, and satisfaction with the tool. The primary outcome of the study is the change in patient activation, measured by the Patient Activation Measure (PAM) at baseline and after six months. Secondary outcomes include changes in health-related quality of life (EORTC-AYA), patient-reported experience measures (PREMs), and a cost-effectiveness evaluation. To detect a clinically meaningful 4-point difference in PAM scores, with an assumed standard deviation of 20 and Type I and II error rates of 5% and 20%, respectively, the study requires 199 participants. Accounting for a 20% dropout rate, a total of 239 participants will be recruited. Primary outcome analysis will be conducted using multivariable logistic regression, while secondary outcomes will be analysed descriptively. Economic evaluation will include cost analysis, cost-utility analysis, and multi-criteria decision analysis. The study will be conducted in compliance with the principles of Good Clinical Practice (ICH/GCP) and the Declaration of Helsinki. The project will be registered at ClinicalTrials.gov. The research team will ensure adherence to all applicable ethical, legal, and safety regulations at both national and EU levels.

Начало: 01.05.2026 Край: 01.06.2027 Възраст: 16–30 г.

Istituto Giannina Gaslini NCT07541183

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Evaluating an AI-Based Mobile Application for Chemotherapy Support in Breast Cancer Patients

Breast Cancer Breast Neoplasm Chemotherapy-Related Toxicities Medication Adherence +3

The goal of this clinical trial is to learn if an Arabic-language mobile application that uses artificial intelligence (AI) can help women with breast cancer during chemotherapy. The app is designed to give personalized support by reminding participants about their medications, teaching them how to manage treatment side effects, and alerting their healthcare team about serious symptoms. The main questions this study aims to answer are: 1. Does the AI-based mobile app provide accurate and safe recommendations for the patients? 2. Does using the AI-based mobile app help lower treatment-related symptoms and side effects compared to usual care? 3. Does the app help participants take their medications more regularly? 4. Does it increase participants' understanding and satisfaction with the information they receive about their treatment? Researchers will compare two groups: Group 1: Participants who use the AI-based mobile app plus usual oncology care. Group 2: Participants who receive usual care only. Participants will: 1. Use the mobile app daily for 12 weeks while receiving chemotherapy. 2. Complete short questionnaires about symptoms, medication use, and quality of life at the start and end of the study. 3. Report any problems or feedback about using the app. The AI app is for support and education only. It does not make treatment decisions. All information from the app will be reviewed by oncologists and pharmacists to ensure participant safety.

Начало: 01.05.2026 Край: 01.10.2026 Възраст: от 18 г.

Iraq Dena h. Al-Tameemi NCT07273812

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Feasibility of Incorporating a Standardized Substance Use Measure With Linked-Brief Intervention Into Routine Psychosocial Care of Adult Childhood Cancer Survivors

Survivors of Childhood Cancer Substance Use

The ASSIST Study is designed to explore whether a brief, evidence based substance use screening and counseling approach can be easily integrated into routine survivorship care at St. Jude Children's Research Hospital. During a regularly scheduled psychosocial visit, participants complete the World Health Organization's Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). This short questionnaire helps identify patterns of use related to tobacco, alcohol, cannabis, prescription medications, and other substances. Survivors whose results show possible risk receive a brief, supportive counseling session during the same appointment. This session uses motivational interviewing techniques to help individuals reflect on their use and consider steps to reduce potential harm. Primary Objective: \- Assess the feasibility and acceptability of implementing a standardized assessment of substance use and brief substance use reduction intervention in survivorship clinical settings. Secondary Objective: \- Evaluate the reliability of delivering a brief substance use intervention to reduce substance use behaviors among Adult Survivors of Childhood Cancer (ASCC) followed in the (ACT) Clinic.

Начало: 01.05.2026 Край: 01.10.2028 Възраст: от 18 г.

United States St. Jude Children's Research Hospital NCT07516301

Предстои набиране Фаза 2

Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)

Metastatic Prostate Cancer

The study is being done to see if a small daily dose of naltrexone (LDN, 3 mg pill) can help reduce tiredness (fatigue) in men with prostate cancer. All men in this study are being treated with hormone therapy (also called androgen deprivation therapy, or ADT). Some may also be taking newer hormone medicines such as apalutamide, daralutamide, enzalutamide, or abiraterone.

Начало: 01.05.2026 Край: 01.01.2029 Възраст: от 18 г.

University of Arkansas NCT07224009

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Individualized Care Perceptions of Patients Receiving Outpatient Chemotherapy: A Qualitative Study

Cancer Patients Care Chemotherapy

The purpose of this observational study is to learn how people receiving chemotherapy in a clinic without staying overnight (outpatient) feel about the care they receive. The study focuses on individualized care, which means nursing care that is tailored specifically to each person's unique needs, values, and lifestyle. Background: Cancer treatment often involves chemotherapy (medicine used to kill cancer cells). While these treatments help fight the disease, they can also cause side effects like nausea or tiredness, which affect daily life. Nurses play a key role in helping people manage these effects. This research aims to understand how "individualized care" helps participants feel valued and supported during their treatment journey. The study aims to answer these key questions: How do participants describe their experiences with nursing care? What are the specific needs and expectations of these individuals for care that feels personal to them? How does personalized care affect their ability to manage symptoms and follow their treatment plan? Scope and Setting: This study will take place at the Yalova Training and Research Hospital within the Outpatient Chemotherapy Unit. The research will be conducted between May 1, 2026, and April 1, 2027. Method and Participants: The researchers plan to interview 10 to 20 participants who are over 18 years old and receiving treatment at the clinic. The final number of participants will be decided when the researchers find that no new information or themes are being discovered in the interviews (a stage called "data saturation"). Participants will: Take part in a private, one-on-one interview with a researcher. Answer open-ended questions about their thoughts and feelings regarding their nursing care. Allow the interview to be voice-recorded to ensure all information is captured accurately. Spend approximately 30 to 45 minutes sharing their personal experiences. Privacy and Ethics: Participant privacy is a top priority. All personal information and voice recordings will be kept strictly confidential. In the final report, fake names (aliases) will be used so that no one can be identified. Participants can choose to leave the study at any time. The study follows international ethical rules to protect the rights of every participant.

Начало: 01.05.2026 Край: 01.04.2027 Възраст: от 18 г.

Turkey (Türkiye) University of Yalova NCT07536945

Предстои набиране Фаза 2

Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers

Gastrointestinal Cancers

This Phase 2 study will be conducted in different countries around the world with up to about 160 participants. The purpose of this study is to evaluate how well Rina-S works against GI cancers. The medication in this study is Rina-S monotherapy (by itself; no other cancer treatments). All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the study treatment is safe and effective. The duration of the study will be different for every participant, but an average study duration of 22 months is expected for participants. This will include a treatment period (expected to last an average of 12 months), plus data collection periods before and after treatment. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of an individual cycle is 21 days). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.

Начало: 01.05.2026 Край: 01.11.2028 Възраст: от 18 г.

Genmab NCT07539311

Предстои набиране Фаза 3

SCRT Based iTNT vs. LCRT Based TNT for MSS Locally Advanced Rectal Cancer

Locally Advanced Rectal Cancer (LARC) MSS (Microsatellite Stable)

In this prospective, multicentre, randomized phase III trial, 612 locally advanced rectal cancer (LARC, T3-4/N+M0) patients with at least one high-risk features (lower location (≤5cm), cT4, cN2, MRF+, EMVI+, TD+) will be included, and randomly assigned to TNT group and iTNT group (1:1). TNT group receives long-course chemoradiotherapy (50Gy/25Fx concurrent with oral capecitabine) followed by 6 cycles of CAPOX. iTNT group receives short-course radiotherapy (25Gy/5Fx) followed by 6 cycles of Serplulimab combined with CAPOX. After the efficacy evaluation, the patients who achieves clinical complete response (cCR) will be managed by a watch and wait (W\&W) protocol and non-cCR patients will be recommended surgery. The primary endpoint is 3-year event-free survival rate (3yEFS%). The secondary endpoints include the complete response (CR, pathological complete response \[pCR\] plus cCR) rate, 3-year organ preservation rate, 3-year disease-free survival rate (3yDFS%), 3-year local recurrence free survival rate (3yLRFS%), 3-year distant metastasis free survival rate (3yDMFS%), 3-year overall survival rate (3yOS%), grade 3-4 acute adverse effects (AE) rate, rate of surgical complications, anal functions and quality of life, etc.

Начало: 01.05.2026 Край: 31.12.2035 Възраст: 18–75 г.

China Fudan University NCT07551479

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Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event

Cytokine Release Syndrome Neoplasms Lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma +12

Background: Drugs or cell therapies to treat cancer can sometimes cause cytokine release syndrome (CRS). That is, the body makes too many cytokines after treatment. Cytokines are proteins that play a role in the immune system. CRS can cause fever, chills, fatigue, low blood pressure, or breathing problems. Researchers want to know if continuously monitoring a person s body temperature can help reduce the chance of getting serious CRS. Objective: To learn if an approved patch called TempTraq can detect fever before serious CRS develops. Eligibility: People aged 18 years and older with cancer who are staying at the NIH clinic for treatment with drugs or cell therapies. Design: Participants will receive TempTraq patches and a special NIH tablet. The TempTraq is a small patch applied to clean, dry skin under the arm. It continually monitors body temperature and sends the data to an application on the tablet. Participants will wear the patch most of the time they are admitted to the hospital. They could wear it for up to 15 days. The patch monitoring does not replace regular temperature checks, all participants will still have have their regular temperature checks as part of their treatment plan. Participants may also opt to use VitalTraq, another application on the tablet. They will hold the screen up to their face for about 1 minute. VitalTraq uses the camera in the tablet to measure blood pressure, heart rate, and breathing. They will do this once per day while they are in the clinic; they may do it more often if they have a fever or feel unwell. Blood may be drawn for research. Participants will be asked about their experience within 1 week after TempTraq is removed. Participants who choose to use the patch, complete its use, and return at a later date for another treatment or study, may be able to re-enroll to have the patch used again.

Начало: 29.04.2026 Край: 18.08.2029 Възраст: 18–120 г.

United States National Cancer Institute (NCI) NCT07499128

Предстои набиране Фаза 1/2

Novel Indenoisoquinolone CMYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma

Recurrent Glioblastoma Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype Relapsed Cancer Recurrent Tumor +11

Background: Glioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells. Objective: To test LMP744 in people with glioblastoma. Eligibility: People aged 18 years or older with glioblastoma that returned after treatment. Design: Participants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function. Participants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a port under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein. LMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time. Participants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery. Participants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits. Participants will continue to have telehealth visits every 3 months after they stop taking the drug.

Начало: 29.04.2026 Край: 31.12.2032 Възраст: 18–99 г.

United States National Institute of Neurological Disorders and Stroke NCT07416188

Предстои набиране Фаза 2

Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers

Core Binding Factor Alpha Subunits Hematologic Neoplasms Leukemia Lymphoma

Background: Some blood cancers can be caused by germline variants (changes) in a person s RUNX1 gene. Germline variants are genetic inherited changes a person is born with. Stem cell transplants are used to treat many diseases including blood cancers. Stem cell transplantation for patients with germline RUNX1 mutation driven blood cancers is standard of care and available in most major medical centers. The difference with this transplantation protocol is that it is prospective, only available to participants with germline RUNX1 variants and designed to determine the extent to which tailoring chemotherapy and supportive care medication doses for each individual patient may improve outcomes compared to data derived from retrospective transplantation protocols for patients with RUNX1 varinats which is less accurate. Objective: The primary objective of this protocol is to determine how tailored doses of chemotherapy and supportive care medications may improve disease free survival as compared to historical/expected disease free survival. Eligibility: People aged 4 to 70 years with blood cancer caused by a RUNX1 gene mutation. Other participants are also needed: (1) stem cell donors; (2) relatives who do not have a mutation in the RUNX1 gene; and (3) healthy volunteers. Design: Participants with blood cancer will be screened during approximately 1-3 months before transplatation. They will have blood tests and tests of their heart and lung function. A sample of bone marrow may be taken. A flexible tube (central line) will be inserted into a vein in participants chest or lower neck. This line will remain in place during the hospitalization and be used to draw blood and administer drugs. These lines are almost always transitioned to a peripherally inserted central catheter (PICC) line at the time of hospital discharge. Participants will be inpatient for 4 to 5 weeks. They will receive drugs to prepare their body for the stem cell transplant. Some may also receive radiation treatment. Other tests will include imaging scans. The stem cell transplant will be given through the central line. After discharge from the clinic, participants will have follow-up visits at least once per week for approximately 100 days. Then they will have follow-up clinic visits for 3 years. Donors, relatives, and healthy volunteers may provide samples of blood, stool, and saliva. Adults may also opt to provide samples of skin and bone marrow.

Начало: 29.04.2026 Край: 01.06.2036 Възраст: 4–70 г.

United States National Cancer Institute (NCI) NCT07524530

Предстои набиране Фаза 2

Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury

Acute Radiation Enteritis

Research Objective and Principle: Through a randomized controlled study, evaluate the effectiveness of dexamethasone in improving radiation-induced rectal injury in rectal cancer patients undergoing pelvic radiotherapy, thereby providing evidence for treatment options in patients at risk of radiation-induced rectal injury and aiming for adoption in international guidelines. Primary Objective: Improvement rate of radiation-induced rectal injury. Secondary Objectives: Severity of radiation-induced rectal injury, completion rate of pelvic radiotherapy, safety of dexamethasone enema, quality of life, pathological complete response (pCR) rate. Study Design: Prospective, single-center, randomized controlled study. Study Population and Expected Enrollment: Patients with rectal cancer undergoing conventional pelvic radiotherapy, expecting to enroll 40 patients. Trial Duration: From February 2026 to February 2028. Intervention: Experimental Group: Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from day 10 of radiotherapy until radiotherapy completion. Control Group: Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from the occurrence of radiation-induced rectal injury until radiotherapy completion. Statistical Hypothesis: Based on previous reports, the incidence of acute radiation-induced rectal injury is 86%, and it is expected that the experimental group can reduce it to 40%. The sample size was estimated using a formula designed to compare 2 proportions, with a set at 0.05 and a power of 80%. The study aimed to enroll at least 36 patients. Considering a dropout rate of 10%, at least 40 patients need to be included.

Начало: 24.04.2026 Край: 24.04.2028 Възраст: 18–75 г.

China Sixth Affiliated Hospital, Sun Yat-sen University NCT07548736

Предстои набиране Фаза 2

A Study of Benmelstobart, Anlotinib, Chemotherapy and Thoracic Radiotherapy for People With Extensive-stage Small Cell Lung Cancer

SCLC, Extensive Stage

This is a single-center, single-arm, exploratory clinical study conducted at Shanghai Pulmonary Hospital, Tongji University. It aims to evaluate the efficacy and safety of first-line treatment with benmelstobart plus anlotinib and chemotherapy (carboplatin/cisplatin plus etoposide), followed by sequential thoracic radiotherapy, in patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be adults aged 18-75 years with histologically or cytologically confirmed ES-SCLC, measurable lesions per RECIST 1.1, ECOG performance status 0-1, and adequate organ function. Patients will receive 4 cycles of induction therapy (benmelstobart, anlotinib, platinum-etoposide chemotherapy). Those without disease progression will receive consolidative thoracic radiotherapy, followed by maintenance therapy with benmelstobart plus anlotinib until disease progression or unacceptable toxicity. The primary endpoint is objective response rate (ORR) assessed by investigators. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety parameters including adverse events graded by CTCAE 5.0. A total of 33 subjects will be enrolled. This study uses a non-randomized, open-label design without a control group.

Начало: 20.04.2026 Край: 31.03.2029 Възраст: 18–75 г.

Yayi He NCT07538271

Предстои набиране Фаза 2

Efficacy and Safety of SKB264 Plus Anlotinib in EGFR-TKI-Resistant Advanced NSCLC With Liver Metastasis

Non-small Cell Lung Cancer EGFR Mutant Advanced Non-small Cell Lung Cancer

The goal of this clinical trial is to learn if the combination therapy with SKB264 and anlotinib works to treat EGFR-TKI-resistant, liver-metastatic non-squamous non-small cell lung cancer (NSCLC). It will also learn about the safety of the combination therapy with SKB264 and anlotinib. The main questions it aims to answer are: Does combination therapy with SKB264 and anlotinib increase response rate and disease control rate, prolong duation of response and progressioin-free survival. What medical problems do participants have when taking combination therapy with SKB264 and anlotinib? Researchers will compare combination therapy with SKB264 and anlotinib to a historical data (the response rate of other drugs reported in literature) to see if combination therapy with SKB264 and anlotinib works better to treat EGFR-TKI-resistant, liver-metastatic non-squamous non-small cell lung cancer (NSCLC). Participants will: 1. receive SKB264 4 mg/kg intravenously on a 14-day cycle, and take anti-H1/H2 antihistamines, acetaminophen, and dexamethasone is recommended before infusion for the first 4 infusions to prevent side effects; the regimen may be simplified starting from the 5th infusion. 2. take anlotinib 10 mg orally once daily for 14 consecutive days, followed by a 7-day rest period. 3. Visit the clinic once every week for checkups and tests

Начало: 20.04.2026 Край: 15.08.2028 Възраст: от 18 г.

China The Fourth Affiliated Hospital of Zhejiang University S NCT07545213

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