NCT07165886

Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors

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)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 243 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 was conducted to evaluate sirolimus for injection (albumin bound) combined with octreotide long-acting injection in patients with unresectable or recurrent GEP-NETs in the first-line setting.

Conditions

• Gastroenteropancreatic Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Sirolimus for injection (albumin bound)	Sirolimus for injection (albumin bound), ivgtt., Q2W
DRUG	Octreotide long-acting injection	SC, Q2W
DRUG	Everolimus	Oral, once a day

Timeline

• Start date: 2025-08-29
• Primary completion: 2028-08-29
• Completion: 2028-08-29
• First posted: 2025-09-10
• Last updated: 2025-09-10

Locations

1 site across 1 country: China