RecruitingPhase 3NCT05884255

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

Randomized, Open, Positive Control Phase III Clinical Trial of Lutetium (177Lu) Oxodotreotide Injection Combined With Standard-dose Long-acting Octreotide Versus High-dose Long-acting Octreotide in the Treatment of Somatostatin Receptor-positive Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

220 participants

Start Date

Jul 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a radioactive drug treatment called lutetium-177 oxodotreotide — which seeks out and targets neuroendocrine tumors — in people with advanced gastrointestinal or pancreatic neuroendocrine tumors that cannot be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old - You have been confirmed by biopsy to have a low-to-intermediate grade (G1 or G2) gastrointestinal or pancreatic neuroendocrine tumor - Your tumor cannot be surgically removed and has spread locally or to other parts of the body - Your general health is good (ECOG 0 or 1) **You may NOT be eligible if...** - You have known cancer spread to the brain (unless previously treated and stable for at least 24 weeks) - You have poorly controlled heart disease or diabetes - You have severe kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLutetium (177Lu) Oxodotreotide Injection;long-acting Octreotide

Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide.

DRUGlong-acting Octreotide

High-dose long-acting Octreotide.


Locations(1)

Tianjin University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

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NCT05884255


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