The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.
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.
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.
Parallel
Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide
DrugLutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide.
long-acting Octreotide
DrugHigh-dose long-acting Octreotide.
Progression-free survival (PFS) assessed by BICR
Overall Survival (OS)
Objective Response Rate (ORR)
Duration of Overall Response (DoR)
Disease Control Rate (DCR)
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