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

Not Applicable

Recruiting

• Conditions: Gastroenteropancreatic Neuroendocrine Tumors
• Interventions: Drug: Sirolimus for injection (albumin bound); Drug: Everolimus; Drug: Octreotide long-acting injection

• Registration Number: NCT07165886
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-29
• Status Verified: 2025-09
• Study First Submitted: 2025-09-03
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10
• Primary Completion: 2028-08-29
• Study Completion: 2028-08-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

• 1. Unresectable locally advanced or metastatic G1/G2 GEP-NETs diagnosed by histology, 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.
• 4. Non-functional GEP-NETs are required.
• 5. At least one measurable lesion that meets the RECIST V1.1 standard.
• 6. ECOG 0~2.
• 7. Organ function reserve is good.
• 8. Be able to sign a written informed consent form.

Exclusion Criteria

• 1. Received treatment with other unlisted clinical investigational drugs within 4 weeks prior to the first use of the investigational drug.
• 2. Undergone major surgical procedures within 4 weeks prior to the first use of the investigational drug and have not fully recovered.
• 3. Received systemic use of corticosteroids or other immunosuppressive therapy within 2 weeks prior to the first use of the study drug.
• 4. With an infection that requires systemic anti-infective treatment within 2 weeks prior to the first use of the study drug.
• 5. Those who have used strong inhibitors or inducers of CYP3A4 liver metabolic enzymes within 2 weeks prior to the first use of the investigational drug or still need to continue using such drugs.
• 6. Has a serious history of cardiovascular and cerebrovascular diseases.
• 7. Having active brain metastasis and/or malignant meningitis.
• 8. With a history of severe lung diseases.
• 9. During screening, there may be symptomatic gallstones or a history of symptomatic gallstones but no surgical treatment has been performed.
• 10. Abnormal thyroid function during screening.
• 11. Known to have hypersensitivity reactions or intolerance to any component of all investigational drugs or their excipients.
• 12. Active hepatitis B, active hepatitis C virus infection, or active syphilis infection.
• 13. History of autoimmune diseases (excluding tuberous sclerosis), history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sirolimus combined with octreotide	Sirolimus for injection (albumin bound)	Sirolimus for injection (albumin bound) combined with octreotide long-acting injection (Q2W) will be administrated on a 28-day cycle
Sirolimus combined with octreotide	Octreotide long-acting injection	Sirolimus for injection (albumin bound) combined with octreotide long-acting injection (Q2W) will be administrated on a 28-day cycle
Sirolimus monotherapy	Sirolimus for injection (albumin bound)	Sirolimus for injection (albumin bound) (Q2W) will be administrated on a 28-day cycle.
Everolimus monotherapy	Everolimus	Everolimus (QD) will be orally administrated on a 28-day cycle. Only for Phase III

Primary Outcome Measures

Name	Time	Method
Phase II: Incidences of Adeverse Events (AEs)	Up to 3 years
Phase II: Maximum tolerated dose (DLT)	Up to 1 year
Phase II: Objective Response Rate (ORR） per investigator	Up to 1 year
Phase II: Recommended Phase 3 Dose (RP3D)	Up to 1 year
Phase III: Progression Free Survival (PFS) per Independent Review Committee (IRC)	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
Phase II: Progression Free Survival (PFS) per investigator	Up to 3 years
Phase II: Duration of Response (DOR) per investigator	Up to 3 years
Phase II: Disease Control Rate (DCR) per investigator	Up to 3 years
Phase III: Duration of Response (DOR)	Up to 3 years
Phase III: Disease Control Rate (DCR)	Up to 3 years
Phase II/III: Overall Survival (OS)	Up to 3 years
Peak Concentration：Cmax	Up to 3 years
Area under the plasma concentration-time curve: AUC	Up to 3 years
Half-Life: t1/2	Up to 3 years
Phase III: Progression Free Survival (PFS) per investigator	Up to 3 years
Phase III: Objective Response Rate (ORR）	Up to 3 years
Phase III: Incidences of Adeverse Events (AEs)	Up to 3 years

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing Municipality, China