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AI · cancer

Намерени 1,748 изпитвания за "cancer" Стр. 50 от 88

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Cancer Survivors' Fear of Cancer Recurrence

Fear of Cacer Recurrence in Cancer Survivorws

The purpose of this study is to develop and evaluate the tailored support for the fear of cancer recurrence in breast, head and neck, colon-rectal or prostate cancer survivors. Based on screening for fear of cancer recurrence, different levels of supportive care will be provided, starting with the oncology nurses' health education and information for those having a lower level of concern. Those who have medium or higher levels of concerns will be randomized to receive "stepping up" either a "ConquerFear psychological cognitive training" or a "healthy lifestyle - individualized exercise and nutrition guidance".

Начало: 15.04.2026 Край: 30.11.2028 Възраст: от 18 г.

National Taipei University of Nursing and Health Scienc NCT07542821

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Real-World Study on Efficacy and Influencing Factors of Immunotherapy for Pan-Cancer Lymph Node Metastases.

Malignant Solid Tumors With Lymph Node Metastasis

Lymph node metastasis is a key stage of malignant tumor progression and a core factor affecting the efficacy of immunotherapy. The therapeutic response of lymph node metastases to immune checkpoint inhibitors (ICIs) varies significantly among different cancer types, and the underlying regulatory mechanisms remain unclear. This single-center, retrospective observational study was approved by the Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University (Approval No.: SYSKY-2026-278-01). We plan to enroll no less than 5000 patients with pan-cancer lymph node metastasis who received ICI therapy in our hospital. The efficacy of primary tumors (T) and metastatic lymph nodes (N) before and after immunotherapy will be evaluated based on TNM staging changes, and the objective response rate (ORR) at both levels will be calculated. Patients will be divided into two groups according to the use of β-blockers during immunotherapy to compare the ORR differences, and explore the clinical factors affecting the efficacy of immunotherapy for pan-cancer lymph node metastases. This study aims to provide evidence-based medical basis for formulating individualized immunotherapy strategies for pan-cancer lymph node metastasis.

Начало: 30.03.2026 Край: 01.05.2027 Възраст: от 18 г.

China Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University NCT07540377

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Superior Mesenteric Artery First Versus Standard Approach in Pancreaticoduodenectomy

Pancreatic Adenocarcinoma Pancreatic Head Cancer

"Pancreatic cancer, especially pancreatic ductal adenocarcinoma, is one of the most serious and deadly cancers. Its outlook is very poor, with fewer than 10% of patients surviving five years after diagnosis. This is largely because the disease is often discovered at a late stage and because it frequently comes back even after surgery. When the tumor is located in the head of the pancreas, the only treatment that can potentially cure the disease is a major operation called a pancreaticoduodenectomy, also known as the Whipple procedure. This surgery is now safely performed in specialized hospitals, but it remains complex and carries a high risk of complications. Importantly, even after surgery, cancer cells often remain, leading to a high rate of local recurrence. A newer surgical technique, known as the "artery-first" approach, changes the order of the operation. By carefully exposing a major blood vessel near the pancreas at the beginning of the surgery, surgeons can better assess whether the tumor can be completely removed and can improve the precision of the operation. This research protocol aims to compare this artery-first technique with the standard surgical approach. The goal is to determine whether starting the operation by addressing the artery allows for more complete tumor removal and reduces the risk of cancer coming back in patients with pancreatic cancer of the head of the pancreas."

Начало: 01.09.2026 Край: 01.09.2031 Възраст: от 18 г.

France Assistance Publique - Hôpitaux de Paris NCT07547033

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Social Media-Based Education on Cancer Screening Awareness in Women: A Randomized Controlled Trial

Cervical Cancer Screening Breast Cancer Screening Colorectal Cancer Screening Digital Health Literacy

This randomized controlled trial investigates the impact of a social media-based educational program on women's knowledge, attitudes, and digital health literacy regarding breast, cervical, and colorectal cancer screenings. The intervention is based on the Socio-Ecological Model and aims to improve awareness and screening participation. Participants in the intervention group receive daily educational content for 8 weeks via social media platforms (WhatsApp/Instagram), while the control group receives two standard online education sessions via Microsoft Teams app. The study includes 132 women aged 30 to 70 in Türkiye who have not previously participated in cancer screenings. The primary outcomes include changes in cancer knowledge, attitudes, and digital health literacy levels measured by validated scales.

Начало: 15.07.2026 Край: 20.08.2026 Възраст: 30–70 г.

Turkey (Türkiye) Emine Ergin NCT06939699

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The Effect Of Motıvatıonal Intervıewıng On Cancer Fear And Partıcıpatıon In Cervıcal Cancer Screenıngs Among Women Lıvıng In Rural Areas

Fear

This research was conducted to determine the effect of a motivational interview-based nursing care program on health beliefs and cancer fears related to cervical cancer and screening in rural women.

Начало: 27.06.2026 Край: 02.09.2026 Възраст: 30–65 г.

Ozge Aslan Koyutürk NCT07540962

Предстои набиране Фаза 2

Testing the SurVaxM Vaccine for Lung Cancer Prevention

Lung Carcinoma

This phase II trial tests how well a survivin peptide vaccine called SurVaxM works in preventing lung cancer in high risk patients. Upon administration, the SurVaxM vaccine activates the immune system to produce an immune cell response against cancer cells that express a protein called survivin. This may result in decreased tumor cell proliferation and lead to tumor cell death. SurVaxM is given with montanide, a substance that helps the immune system respond to the SurVaxM vaccine, followed by sargramostim, which is given to increase the number of white blood cells in the body. The SurVaxM vaccine may help the body make special proteins called antibodies, which may be helpful in preventing the development of lung cancer.

Начало: 01.06.2026 Край: 30.09.2029 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT07169617

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A Spiritual Health Intervention (PATH) for Improving Spiritual, Religious and Emotional Distress in Cancer Patients

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

This clinical trial tests the feasibility and effectiveness of a spiritual health intervention (Personal Archetypes Toward Healing Trial \[PATH\]) for improving spiritual, religious and existential distress in patients with cancer. Many patients with cancer find their diagnosis to elicit challenges to their sense of connection, meaning, and purpose. This distress can significantly impact their quality of life. However, spiritual care interventions are often overlooked. PATH builds on multiple theories and therapeutic practices such as role-playing, archetype psychology, cognitive theory, emotion regulation therapy, and dignity therapy. PATH sessions cover topics such as individuation, intrapersonal meaning and worth, intrapersonal distress and faith, interpersonal distress and faith, and transpersonal distress and faith. The PATH intervention may help cancer patients shift their perspectives and access new insights for working through their spiritual, religious and existential distress.

Начало: 01.06.2026 Край: 31.03.2027 Възраст: от 18 г.

United States Fred Hutchinson Cancer Center NCT07545291

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Oncology Acute Care Follow-up Intervention Study

Cancer

This pragmatic randomized controlled study evaluates an education intervention designed to increase patient engagement with Oncology Acute Care (OAC) services among patients being treated for cancer at Parkland Health. Eligible patients will be randomized to either a control (usual care) arm or an intervention arm. If a patient in the control group has experiences a subsequent cancer treatment related ED visit without documented OAC engagement, they will be moved to the intervention arm. Patients in the intervention arm will receive an automated MyChart message and text message within 24 hours of hospital discharge reinforcing oncology acute care (OAC) resources, including contact information for the triage line and guidance for when to seek urgent versus emergency care. Messages will be resent at 48 and 72 hours if unviewed. Once the message is viewed, the patient will enter an outcome tracking period to monitor time to subsequent ED visit or OAC contact. Follow-up will occur in 3-month intervals until an outcome is documented or the study ends. After randomization, patients will be monitored on an observation list for outcomes including OAC contact and cancer treatment-related Emergency Department (ED) visits. Patients who contact OAC clinic will be removed from observation list and complete the study. We will repeat the observation period and document outcomes if the patient has a subsequent cancer treatment-related ED visits without documented OAC engagement.

Начало: 15.05.2026 Край: 31.08.2028 Възраст: от 18 г.

United States University of Texas Southwestern Medical Center NCT07550192

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Iparomlimab and Tuvonralimab Plus Chemotherapy Before Surgery for Stage III Lung Cancer

Carcinoma, Non-Small-Cell Lung (NSCLC) Neoplasm Staging Lymphatic Metastasis

Background: For patients with resectable stage III-N2b non-small cell lung cancer (NSCLC), optimal perioperative treatment strategies remain an area of active investigation. Iparomlimab and tuvonralimab (QL1706) is a novel bifunctional antibody combination targeting PD-1 and CTLA-4, designed to enhance anti-tumor immunity. Objective: This phase II, single-arm, multicenter study aims to evaluate the efficacy and safety of neoadjuvant iparomlimab and tuvonralimab (QL1706) in combination with platinum-based chemotherapy in patients with resectable stage III-N2b NSCLC. Study Design and Methods: A total of 28 patients will be enrolled across approximately 4 centers in China. Eligible patients (aged ≥18 years, ECOG PS 0-1) with histologically or cytologically confirmed, resectable stage III-N2b NSCLC (AJCC 9th edition) will receive three cycles of neoadjuvant therapy every three weeks. Patients with non-squamous carcinoma will receive iparomlimab and tuvonralimab (5 mg/kg) plus pemetrexed (500 mg/m²) and carboplatin (AUC 5). Patients with squamous carcinoma will receive iparomlimab and tuvonralimab (5 mg/kg) plus nab-paclitaxel (260 mg/m²) and carboplatin (AUC 5). Surgical resection will be performed within 6 weeks following completion of neoadjuvant therapy. Subsequent adjuvant treatment is at the discretion of the investigator. Key Eligibility Criteria: Key inclusion criteria include pathologically confirmed T\any\N2b disease with mediastinal nodal status confirmed by EBUS/EUS or mediastinoscopy, and the determination by multidisciplinary team (MDT) assessment that the tumor is completely resectable (R0). Key exclusion criteria include known EGFR or ALK positive mutations, prior anti-cancer therapy for current lung cancer, active autoimmune disease, or uncontrolled hepatitis B or C. Study Endpoints: The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), R0 resection rate, event-free survival (EFS), overall survival (OS), impact on surgical outcomes, and safety. Exploratory endpoints involve biomarker analysis including ctDNA. Sample Size Rationale: Assuming a null hypothesis pCR rate (P0) of 8.8% (based on historical data) and an expected pCR rate (P1) of 28%, with a two-sided α of 5% and 80% power, 24 patients are required. Factoring in a 15% inoperable rate, the total sample size is 28 patients. Statistical Analysis: The primary endpoint, pCR rate, and other binary endpoints will be summarized with frequencies, percentages, and their 95% confidence intervals calculated using the Clopper-Pearson method. Time-to-event endpoints (EFS, OS) will be analyzed using the Kaplan-Meier method. Safety data will be summarized descriptively. Clinical Trial Information: This study is sponsored by The Second Affiliated Hospital of Air Force Medical University, PLA. The Principal Investigator is Dr. Yan Xiaolong.

Начало: 01.05.2026 Край: 01.12.2029 Възраст: от 18 г.

China Tang-Du Hospital NCT07538193

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Using e-Technologies to Maximize Physical Activity After Cancer Treatment

Cancer

The Cancer Exercise app (CEA) is designed to promote physical activity among cancer survivors. The proposed randomized controlled clinical trial will investigate, in adults who have completed cancer treatment, the effects of a 12-week home-based exercise program, delivered using CEA, on physical activity levels. Participants will be randomized into one of two groups: (1) CEA or (2) Usual Care.

Начало: 01.05.2026 Край: 01.05.2028 Възраст: 18–85 г.

University of Florida NCT07535918

Предстои набиране Фаза 1/2

ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1

Merkel Cell Carcinoma Merkel Cell Carcinoma, Stage III Merkel Cell Carcinoma, Stage IV

The goal of this clinical trial is to learn if ASTX727 can be combined with retifanlimab to treat Merkel cell cancer. It will also learn about the safety of combining these drugs. The main questions it aims to answer are: * Can the combination shrink cancer and lower the chance of the cancer growing or spreading? * Is the combination better than standard of care for Merkel cell cancer? Participants will: * Take oral ASTX727 and retifanlimab through a vein in the arm for about 2 years. * Visit the clinic once every 2 weeks for checkups and tests

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

United States University of Wisconsin, Madison NCT07472322

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Study to Assess Prevalence of the Folate Receptor Alpha (FRa) in Adult Female Participants With Ovarian Cancer in Intercontinental (InterCon) Countries

Ovarian Cancer

Epithelial ovarian cancer (OC), including fallopian tube and primary peritoneal cancer, is the deadliest gynecologic malignant neoplasm with a 5-year relative survival of approximately 50%. This study will evaluate the concordance in folate receptor alpha (FRa) immunohistochemistry (IHC) in adult female participants with ovarian cancer. Archived tissue biopsies will be tested for FRa and data from approximately 1,000 participants will be collected. This is a retrospective study and testing will be performed prospectively on archived samples. Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the study will be approximately 1 Year. There is no additional burden for participants in this trial.

Начало: 01.05.2026 Край: 01.03.2027 Възраст: от 18 г.

AbbVie NCT07539844

Предстои набиране Фаза 2

CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia B-All

Background: Acute lymphoblastic leukemia (ALL) is a type of blood cancer. Chimeric antigen receptor (CAR) therapy involves taking immune cells (T cells) from a person and modifying them to better target cancer cells. CAR T-cell therapy that targets a marker called CD19 has been show to can cure ALL in many children and adults. But in about 50% of patients, the ALL comes back within a year. Researchers want to find out if a second treatment with CAR T-cell therapy that targets a different marker, CD22, can keep the cancer away longer. Objective: To see if CD22 CAR T-cell therapy can keep ALL away longer. Eligibility: People aged 3 to 65 years who have no signs of cancer after CD19 CAR T-cell treatment for ALL. Design: Participants will be screened. They will have imaging scans and tests of their heart function. A sample of tissue (biopsy) will be collected from their bone marrow. They will have a fluid sample collected from the area around their spinal cord. Participants will undergo collection of their white blood cells (T cells) during a procedure called leukapheresis. Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein. The cells will be altered in a lab to create CD22 CAR T-cell therapy. Participants will take drugs over 4 consecutive days to prepare their body for the CAR T-cell therapy; then they will receive their modified T cells through a tube inserted into a vein. Some people may need to stay in the hospital during treatment. Participants will have follow-up visits for 2 years.

Начало: 29.04.2026 Край: 31.01.2031 Възраст: 3–65 г.

United States National Cancer Institute (NCI) NCT07328503

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Impact of Pharmacist-Led Intervention on Adult Oncology Outpatients

Cancer

Background and Rationale: Cancer patients receiving outpatient therapy often manage complex medication regimens that include anticancer agents, supportive care medications, and treatments for chronic comorbidities. This polypharmacy greatly increases the risk of medication discrepancies, potential drug-drug interactions, and unintentional errors. Moreover, because most oncology care is delivered in outpatient settings, patients are primarily responsible for self-administering their medications, making adherence a key determinant of treatment success and patient safety (Lindenmeyer et al., 2022; Alshehri et al., 2024). Medication errors and poor adherence among oncology patients are widely recognized global concerns. Research indicates that nearly half of cancer patients experience at least one medication discrepancy during transitions of care, and nonadherence to oral anticancer therapies can exceed 40%. Such issues can result in reduced treatment efficacy, increased toxicity, avoidable hospitalizations, higher healthcare costs, and poorer quality of life (Weingart et al., 2018; Wu et al., 2020; Patel et al., 2021). Pharmacists, as essential members of the multidisciplinary oncology team, are uniquely positioned to address these medication-related challenges. Their pharmacotherapy expertise and patient-education roles enable them to detect discrepancies, optimize medication use, and enhance patient understanding of treatment regimens. Evidence from various healthcare settings shows that pharmacist-led interventions such as medication reconciliation, individualized counseling, and structured follow-up can improve medication safety and adherence (de Clercq et al., 2021; Boeni et al., 2022). Despite strong evidence supporting each of these interventions individually, few studies have examined the combined effect of pharmacist-led reconciliation, counseling, and follow-up in outpatient oncology practice. Adult cancer patients face additional challenges, including complex dosing schedules, emotional distress, and financial burdens, all of which can impair medication adherence. An integrated pharmacist led program may create a continuous safety net that detects medication discrepancies early, reinforces correct use, and sustains adherence throughout treatment (Gellad et al., 2022; ISPOR Report, 2023). Therefore, this study aims to evaluate the impact of a comprehensive pharmacist-led program encompassing medication reconciliation, individualized counseling, and systematic follow-up on enhancing medication adherence and reducing medication errors among adult outpatient cancer patients. Demonstrating the effectiveness of this integrated care model may provide strong evidence to support the routine inclusion of pharmacists in outpatient oncology services to improve patient outcomes and medication safety (Alshehri et al., 2024; Boeni et al., 2022). Study Hypothesis: Adult oncology outpatients are frequently prescribed complex medication regimens upon leaving the hospital. Therefore, this study aims to evaluate whether a comprehensive pharmacist-led outpatient program improves medication adherence and reduces medication errors among this population.

Начало: 20.04.2026 Край: 20.07.2026 Възраст: 18–65 г.

Badr University NCT07550478

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Evaluating Ovarian Toxicity Outcomes Following Immunotherapy in Patients With Triple-Negative Breast Cancer (TNBC)

Triple Negative Breast Cancer (TNBC)

This study aims to collect information about the effects of chemotherapy combined with immunotherapy (immune checkpoint inhibitors) for early-stage triple-negative breast cancer (TNBC) on ovarian function and fertility. You may be eligible for this study if you have been diagnosed with early-stage TNBC and are planning to receive neoadjuvant chemotherapy combined with immunotherapy before surgery. Additional eligibility criteria apply. Participants who choose to enroll will be asked to complete questionnaires and provide blood samples before and after treatment to measure hormone levels related to ovarian function. Information about menstrual patterns, fertility preservation discussions, and reproductive health will also be collected. Some participants may undergo ultrasound assessments to evaluate ovarian reserve and endometrial thickness. Follow-up will continue for up to 24 months after treatment to assess long-term ovarian function. No additional or experimental cancer treatments will be provided as part of this study. This is an observational study only, and participants will receive standard cancer treatment as recommended by their treating team. It is hoped this research will provide important information about the potential effects of chemotherapy and immunotherapy on ovarian health and fertility in women receiving treatment for early-stage TNBC.

Начало: 08.04.2026 Край: 31.12.2031 Възраст: 18–42 г.

Australia Peter MacCallum Cancer Centre, Australia NCT07527819

Предстои набиране Фаза 2

Nab-Paclitaxel Combined With Local Therapy in Relapsed SCLC

Small Cell Lung Cancer Extensive Stage Small Cell Lung Cancer (ES-SCLC)

This is a prospective, single-arm, investigator-initiated clinical study (IIT) designed to evaluate the efficacy and safety of nab-paclitaxel combined with local radiotherapy for patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed after first-line treatment. Small cell lung cancer (SCLC) is an aggressive type of lung cancer, and extensive-stage SCLC (ES-SCLC) refers to its advanced stage. For patients whose cancer progresses after first-line treatment, there are very limited effective second-line and later-line treatment options. Commonly used clinical regimens such as topotecan and lurbinectedin only provide modest improvements in tumor response and survival, and often cause severe hematological toxicities (represented by bone marrow suppression). This leaves patients in a persistent dilemma of "insufficient efficacy and limited tolerability", highlighting a clear unmet medical need for better treatment options in this population. Against this background, this study explores a comprehensive treatment strategy using nab-paclitaxel as the chemotherapy backbone, combined with local radiotherapy in eligible patients. Nab-paclitaxel is a nanoparticle albumin-bound form of paclitaxel, with a relatively controllable toxicity profile and manageable administration in clinical practice. Local radiotherapy may create a synergistic effect by improving the tumor immune microenvironment and enhancing local tumor control, with the goal of providing better evidence for a "chemotherapy ± local therapy" combination as a second-line treatment option.

Начало: 06.04.2026 Край: 31.12.2030 Възраст: 18–75 г.

Shanghai Pulmonary Hospital, Shanghai, China NCT07547332

Предстои набиране Фаза 1/2

Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Pemetrexed + Cisplatin Therapy

Nonsquamous Nonsmall Cell Neoplasm of Lung

Maitake is reported with immunomodulatory functions against tumor growth in terms of its unique molecular structure, β-glucan polysaccharides within 1, 6 main chain having 1, 3 branches and a 1, 3 main chain having 1, 6 branches configuration. The β-glucan is identified as a main component of BLEX 404. Not only with therapeutic potential on several types of cancer, BLEX 404 has also shown the potential to improve hematopoiesis, granulocyte colony stimulating factor (G-CSF) production, and the cytotoxicity activity of immune cells in recent animal studies. Its antitumor effect on tumor-bearing mice is exerted by enhancing the immune system through activation of macrophages, T cells, and natural killer (NK) cells. The activation of antigen presenting cells (APCs) such as macrophages, dendritic cells (DCs) via BLEX 404 administration is in response to secretion of interleukin-12 (IL-12). BLEX 404 has been found to enhance the activity of immunocompetent cells such as helper T cells, cytotoxic T cells, and NK cells either by i.p injection or oral intake, therefore, it stimulates innate and adaptive immunity. BLEX 404 enhances hematopoiesis by increasing mouse bone marrow cell and human cord blood cell differentiation into granulocytes-macrophages (GMs), granulopoiesis and mobilization of granulocytes, and granulocyte macrophage colony-stimulating factor (GM-CSF) or G-CSF production. One related phase I healthy human trial by treating with Maitake D-fraction was examined in Italy. The published data of trial for solid tumor patients was in the year 2003 in Japan, and another for breast cancer patients was in the year 2009 in the United States executed by Memorial Sloan Kettering Cancer Center (MSKCC). Lately, same team amended IND for myelodysplastic syndromes (MDS) human trial. All those human experiences are the fundamental of developing BLEX 404 Oral Liquid.

Начало: 01.12.2026 Край: 31.12.2028 Възраст: 20–70 г.

Taiwan Rgene Corporation NCT05764928

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ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer

Rectal Cancer Non Metastatic Rectal Cancer

This prospective observational, non-therapeutic study for patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy. This research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor DNA (genetic material) ctDNA will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care C2i Genomics, a biotechnology company, and the Spier Foundation are supporting this research study by providing funding for the study.

Начало: 01.10.2026 Край: 01.06.2030 Възраст: от 18 г.

United States Massachusetts General Hospital NCT05629442

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SHAPE-ENDO: Multimodal Pre-Surgical Optimization in Patients With Obesity and Early-Stage Endometrial Cancer (Phase 1)

Endometrial Cancer Endometrial Cancer Stage I Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I Atypical Endometrial Hyperplasia +5

SHAPE-ENDO is a prospective, single-center, observational cohort study conducted at Hospital Universitari de Bellvitge (Barcelona, Spain), designed to evaluate a multimodal pre-surgical optimization strategy in women with severe obesity (BMI ≥40 kg/m²) and atypical endometrial hyperplasia or early-stage, low-risk endometrial cancer. This strategy reflects current clinical practice in selected patients in whom immediate surgery may be associated with increased perioperative risk due to obesity and comorbidities. Instead of upfront surgery, patients undergo a structured optimization program aimed at improving metabolic status while maintaining local oncologic control. The multimodal intervention includes standard-of-care treatments: * Pharmacological metabolic therapy with glucagon-like peptide-1 receptor agonists (GLP-1 RAs, e.g., semaglutide) or dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonists (GIP/GLP-1 RAs, e.g., tirzepatide), according to clinical indication and availability * Local hormonal treatment with a levonorgestrel-releasing intrauterine device (LNG-IUD), with or without oral progestins * Structured nutritional intervention * Supervised physical exercise program * Scheduled clinical, imaging, and histological surveillance The study is structured in two phases: Phase 1 (prospective cohort phase): Participants are followed during a 28-54 week prehabilitation period to evaluate the proportion of patients achieving predefined optimization criteria, including significant weight loss, improved metabolic status, adequate anesthetic risk profile, and absence of tumor progression. Secondary outcomes include histological response, treatment adherence, quality of life, and feasibility of subsequent surgical management. Phase 2 (long-term follow-up and comparative phase): Participants from the prospective cohort will be followed longitudinally for a minimum of 5 years to assess overall survival, disease-specific survival, recurrence rates, long-term metabolic outcomes, and quality of life. In addition, outcomes will be compared with a historical cohort of patients with similar baseline characteristics (BMI ≥40 kg/m²) previously treated at the same institution, with particular focus on surgical morbidity and survival outcomes. All interventions are part of routine clinical care and are administered according to current clinical guidelines and physician judgment. The primary objective of the study is to evaluate whether this multimodal strategy can improve surgical eligibility and reduce perioperative risk without compromising oncologic safety, while potentially impacting long-term survival and quality of life in this high-risk population. Findings from SHAPE-ENDO may provide evidence to support a paradigm shift toward integrated metabolic and oncologic management in patients with obesity and early-stage endometrial cancer, and may inform future controlled comparative studies.

Начало: 01.09.2026 Край: 01.09.2028 Възраст: от 18 г.

Hospital Universitari de Bellvitge NCT07462663

Предстои набиране Фаза 2

Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This phase II trial studies how well the addition of nemtabrutinib to lisocabtagene maraleucel in treating patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Nemtabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lisocabtagene maraleucel is a type of treatment called chimeric antigen receptor (CAR) T-cell therapy, in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T-cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion for treatment. Adding nemtabrutinib to lisocabtagene maraleucel may be an effective treatment for relapsed/refractory CLL/SLL.

Начало: 01.07.2026 Край: 20.10.2029 Възраст: от 18 г.

United States Fred Hutchinson Cancer Center NCT07194980

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