There is limited evidence regarding the benefit of adding somatostatin analogs to molecular targeted agents for well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with poor prognostic factors. This trial is conducted to evaluate sirolimus for injection (albumin bound) combined with octreotide long-acting injection in patients with unresectable or recurrent GEP-NETs.
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Phase II: Incidences of Adeverse Events (AEs)
Timeframe: Up to 3 years
Phase II: Dose Limiting Toxicity (DLT)
Timeframe: Up to 1 year
Phase II: Recommended Phase 3 Dose (RP3D)
Timeframe: Up to 1 year
Phase II: Objective Response Rate (ORR) per investigator
Timeframe: Up to 1 year
Phase III: Progression Free Survival (PFS) per Blinded Independent Review Committee (BIRC)
Timeframe: Up to 3 years
Clinical Trials Information Group officer