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

RecruitingPhase 3Ages 18 Years - 75 YearsAllJiangsu HengRui Medicine Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Lutetium (177Lu) Oxodotreotide Injection;long-acting Octreotide
  • long-acting Octreotide
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Where

2 sites
Fudan University Shanghai Cancer Center
Shanghai, China
Tianjin University Cancer Institute and Hospital
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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