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

NCT ID: NCT07165886

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-29
• Study Completion Date: 2028-08-29

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.

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sirolimus combined with octreotide

Sirolimus for injection (albumin bound) combined with octreotide long-acting injection (Q2W) will be administrated on a 28-day cycle

Group Type: EXPERIMENTAL

Sirolimus for injection (albumin bound)

Intervention Type: DRUG

Sirolimus for injection (albumin bound), ivgtt., Q2W

Octreotide long-acting injection

Intervention Type: DRUG

SC, Q2W

Sirolimus monotherapy

Sirolimus for injection (albumin bound) (Q2W) will be administrated on a 28-day cycle.

Group Type: EXPERIMENTAL

Sirolimus for injection (albumin bound)

Intervention Type: DRUG

Sirolimus for injection (albumin bound), ivgtt., Q2W

Everolimus monotherapy

Everolimus (QD) will be orally administrated on a 28-day cycle. Only for Phase III

Group Type: ACTIVE_COMPARATOR

Everolimus

Intervention Type: DRUG

Oral, once a day

Interventions

Sirolimus for injection (albumin bound)

Sirolimus for injection (albumin bound), ivgtt., Q2W

Intervention Type: DRUG

Octreotide long-acting injection

SC, Q2W

Intervention Type: DRUG

Everolimus

Oral, once a day

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Clinical Trials Information Group officer

Role: CONTACT

ctr-contact@cspc.cn

86-0311-69085587

Other Identifiers

HB1901-010

Identifier Type: -

Identifier Source: org_study_id