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.
1. Unresectable locally advanced or metastatic G1/G2 GEP-NETs diagnosed by histology, according to the 2019 WHO histological grading criteria.
2. Having poor prognostic factors.
3. Non-functional GEP-NETs are required.
4. At least one evaluable lesion meets the RECIST V1.1 standard (Applicable only to the phase II safety run-in stage)
1. Patients who have previously received SSTR-targeted therapies (including somatostatin analogs [SSAs] and peptide receptor radionuclide therapy) and/or mTOR inhibitors (Patients who received SSAs in the adjuvant setting and experienced recurrence ≥6 months after treatment completion may be enrolled)[ Applicable to Phase II dose expansion and Phase III stages].
2. Has uncontrolled/severe diarrhea or an axillary temperature > 38.0°C at enrollment.
3. Received treatment with other unlisted clinical investigational drugs within 4 weeks prior to the first use of the investigational drug.
4. Undergone major surgical procedures within 4 weeks prior to the first use of the investigational drug and have not fully recovered.
Parallel
Sirolimus for injection (albumin bound)
DrugSirolimus for injection (albumin bound), ivgtt.
Octreotide long-acting injection
DrugSC
Everolimus
DrugOral, once a day
Phase II: Incidences of Adeverse Events (AEs)
Phase II: Dose Limiting Toxicity (DLT)
Phase II: Recommended Phase 3 Dose (RP3D)
Phase II: Objective Response Rate (ORR） per investigator
Phase II: Duration of Response (DOR) per investigator
Phase II: Disease Control Rate (DCR) per investigator
Phase II: Progression Free Survival (PFS) per investigator
Phase II: Overall Survival (OS)
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