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

NCT07165886 | Recruiting Phase 2 DMC

• 1 other identifier: HB1901-010
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

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

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (5)

• Phase II: Incidences of Adeverse Events (AEs)

  Up to 3 years

• Phase II: Dose Limiting Toxicity (DLT)

  Up to 1 year

• Phase II: Recommended Phase 3 Dose (RP3D)

  Up to 1 year

• Phase II: Objective Response Rate (ORR） per investigator

  Up to 1 year

• Phase III: Progression Free Survival (PFS) per Blinded Independent Review Committee (BIRC)

  Up to 3 years

Secondary Outcomes (16)

• 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 II: Progression Free Survival (PFS) per investigator

  Up to 3 years

• Phase II: Overall Survival (OS)

  Up to 3 years

• Peak Concentration：Cmax

  Up to 3 years

Study Arms (3)

Sirolimus combined with octreotide

EXPERIMENTAL

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

Drug: Sirolimus for injection (albumin bound); Drug: Octreotide long-acting injection

Sirolimus monotherapy

EXPERIMENTAL

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

Drug: Sirolimus for injection (albumin bound)

Everolimus monotherapy

ACTIVE COMPARATOR

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

Drug: Everolimus

Interventions

Octreotide long-acting injection DRUG

SC

Sirolimus combined with octreotide

Everolimus DRUG

Oral, once a day

Everolimus monotherapy

Sirolimus for injection (albumin bound) DRUG

Sirolimus for injection (albumin bound), ivgtt.

Sirolimus combined with octreotide; Sirolimus monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Unresectable locally advanced or metastatic G1/G2 GEP-NETs diagnosed by histology, according to the 2019 WHO histological grading criteria.
• \. Having poor prognostic factors.
• \. Non-functional GEP-NETs are required.
• \. At least one evaluable lesion meets the RECIST V1.1 standard (Applicable only to the phase II safety run-in stage)
• \. ECOG 0\~2.
• \. Organ function reserve is good.
• \. Be able to sign a written informed consent form.

You may not qualify if:

• \. Patients who have previously received SSTR-targeted therapies (including somatostatin analogs \[SSAs\] and peptide receptor radionuclide therapy) and/or mTOR inhibitors (Patients who received SSAs in the adjuvant setting and experienced recurrence ≥6 months after treatment completion may be enrolled)\[ Applicable to Phase II dose expansion and Phase III stages\].
• \. Has uncontrolled/severe diarrhea or an axillary temperature \> 38.0°C at enrollment.
• \. Received treatment with other unlisted clinical investigational drugs within 4 weeks prior to the first use of the investigational drug.
• \. Undergone major surgical procedures within 4 weeks prior to the first use of the investigational drug and have not fully recovered.
• \. Received systemic use of corticosteroids or other immunosuppressive therapy within 2 weeks prior to the first use of the study drug.
• \. With an infection that requires systemic anti-infective treatment within 2 weeks prior to the first use of the study drug.
• \. 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.
• \. Has a serious history of cardiovascular and cerebrovascular diseases.
• \. Having active brain metastasis and/or malignant meningitis.
• \. With a history of severe lung diseases.
• \. During screening, there may be symptomatic gallstones or a history of symptomatic gallstones but no surgical treatment has been performed.
• \. Abnormal thyroid function during screening.
• \. Known to have hypersensitivity reactions or intolerance to any component of all investigational drugs or their excipients.
• \. Active hepatitis B, active hepatitis C virus infection, or active syphilis infection.
• \. 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.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

Sirolimus; Injections; Everolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: August 29, 2025
• Primary Completion (Estimated): August 29, 2028
• Study Completion (Estimated): August 29, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CN (1)