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Recruiting Phase 3 NCT05884255

An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.

Phase 3 – large-scale trial before approval
Conditions: Advanced Gastroenteropancreatic Neuroendocrine Tumor

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

trial.available_in: БГ
Overview
The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.
Who can participate
Inclusion Criteria: 1. Able and willing to provide a written informed consent; 2. 18\~75 years old,male or female; 3. ECOG performance status 0 or 1; 4. Unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors (GEP-NETs) of low and medium grade (G1 or G2) confirmed by histopathology. Exclusion Criteria: 1. Central nervous system metastasis is known. Patients who have previously received treatment ( radiotherapy or surgery ) for brain metastases and have no clinical symptoms can be enrolled if the pre-randomized pre-imaging is confirmed to be stable for at least 24 weeks; 2. There are clinical symptoms or diseases of the heart that are not well controlled; 3. Diabetes (fasting blood glucose \> 2 × ULN) that cannot be well controlled after optimal medical support treatment; 4. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason.
Interventions
Lutetium (177Lu) Oxodotreotide Injection;long-acting Octreotide
DRUG
long-acting Octreotide
DRUG
Locations 1
China (1)
Tianjin University Cancer Institute and Hospital
Tianjin , Tianjin Municipality
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
06.07.2023
Completion date
01.10.2030
Registry ID
NCT05884255
Source
clinicaltrials.gov
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