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.
Jiangsu HengRui Medicine Co., Ltd.
220 participants
Jul 6, 2023
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
Inclusion Criteria4
- Able and willing to provide a written informed consent
- \~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 ;
Exclusion Criteria4
- Central nervous system metastasis is known. Patients who have previously received treatment ( radiotherapy or surgery ) for brain metastases and have no clinical symptoms can be enrolled if the pre-randomized 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 incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason
Interventions
Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide
High-dose long-acting Octreotide.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05884255