An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
Recruiting
Phase 3
Interventional Study
Advanced Gastroenteropancreatic Neuroendocrine Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 220 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
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About This Trial
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 Locations
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Eligibility Criteria
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 hist…
Contacts