Eligibility criteria+411 characters
[...] , according to the 2019 WHO histological grading criteria.
2. Have not received systemic anti-tumor treatment for neuroendocrine tumors in the past.
3. Having poor prognostic factors.
43. Non-functional GEP-NETs are required.
54. At least one measurableevaluable lesion that meets the RECIST V1.1 standard. (Applicable only to the phase II safety run-in stage)
6. ECOG 0~2.
7. Organ function reserve is good.
8. Be able [...] sign a written informed consent form.
Exclusion Criteria:
1. Patients who have previously received SSTR-targeted therapies (including somatostatin analogs [SSAs] and peptide recep [...] [...]
Secondary endpoints12 to 16 entries
Phase II/: Overall Survival (OS)
Phase II: Blood concentrations and PK parameters of sirolimus for injection(albumin bound) and Octreotide long-acting injection.
Phase II: Changes in serum chromogranin A, 24-hour urinary 5-hydroxyindoleacetic acid, and serum IGF-1 levels from baseline.
Phase III: Overall Survival (OS)
Phase III: Changes in serum chromogranin A, 24-hour urinary 5-hydroxyindoleacetic acid, and serum IGF-1 levels from baseline.
Primary endpoints5 entries, revised
Phase II: MaximumDose toleratedLimiting doseToxicity (DLT)
Phase III: Progression Free Survival (PFS) per Blinded Independent Review Committee (IRCBIRC)