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

StatusRecruiting
PhasePhase 3
Started2023-07-06
View on ClinicalTrials.gov ↗

Amendment history

2026-05-15
Study Status, Outcome Measures, Contacts/Locations v3
Study sites1→2
Secondary endpoints5 entries, revised
Disease Control Rate (DCR) Incidence and severity of adverse event (AE) and serious adverse event (SAE)
2026-04-14
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v2
InterventionsLutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide (Drug), long-acting Octreotide. (Drug)→Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide (Drug), long-acting Octreotide (Drug)
Eligibility criteria-4 characters
Inclusion Criteria: 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 gastrointestina [...] low and medium grade (G1 or G2) confirmed by histopathology ;. Exclusion Criteria: Central nervous system metastasis is kn [...] pre-imaging is confirmed to be stable for at least 24 weeks.; There are clinical symptoms or diseases of the heart that are not well controlled.; Diabetes (fasting blood glucose > 2 × ULN) that cannot be well controlled after optimal medical support treatment.; Severe urinary [...] [...]
2023-08-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-06→confirmed 2023-07-06
Study sites0→1
2023-05-22
Original filing
The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.
Trial Details
NCT Number NCT05884255
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Advanced Gastroenteropancreatic Neuroendocrine Tumor
Enrollment 220 participants
Start Date 2023-07-06
Primary Completion 2026-12 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2026-05-19