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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Able and willing to provide a written informed consent
• 18\
⁃ 75 years old,male or female；
• ECOG performance status 0 or 1
• Unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors ( GEP-NETs ) of low and medium grade ( G1 or G2 ) confirmed by histopathology ;
Locations
Other Locations
China
Tianjin University Cancer Institute and Hospital
RECRUITING
Tianjin
Contact Information
Primary
Xueying Zheng
xueying.zheng.xz17@hengrui.com
+0518-82342973
Time Frame
Start Date: 2023-07-06
Estimated Completion Date: 2030-10
Participants
Target number of participants: 220
Treatments
Experimental: Treatment group A
Active_comparator: Treatment group B
Related Therapeutic Areas
Sponsors
Leads: Jiangsu HengRui Medicine Co., Ltd.