NCT05884255

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Gastroenteropancreatic Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide	Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide.
DRUG	long-acting Octreotide	High-dose long-acting Octreotide.

Timeline

• Start date: 2023-07-06
• Primary completion: 2026-12-01
• Completion: 2030-10-01
• First posted: 2023-06-01
• Last updated: 2026-04-17

Locations

1 site across 1 country: China