Phase II/III Study to Evaluate the Safety and Efficacy of Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
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)
• 6\. ECOG 0\
• 7\. Organ function reserve is good.
• 8\. Be able to sign a written informed consent form.