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

Status

Recruiting

Phase

Phase 2 / Phase 3

Enrollment

298

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Sirolimus for injection (albumin bound)

Sirolimus for injection (albumin bound), ivgtt.

DRUG

Octreotide long-acting injection

SC

DRUG

Everolimus

Oral, once a day

Timeline

From registration to results.

  1. First posted

    Sep 10, 2025

  2. Study start

    Aug 29, 2025

  3. Primary completion

    Aug 29, 2028

  4. Study completion

    Aug 29, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Apr 24, 2026

Outcomes

What the study measures.

Primary outcomes

Phase II: Incidences of Adeverse Events (AEs)

Time frame · Up to 3 years

Phase II: Dose Limiting Toxicity (DLT)

Time frame · Up to 1 year

Phase II: Recommended Phase 3 Dose (RP3D)

Time frame · Up to 1 year

Phase II: Objective Response Rate (ORR) per investigator

Time frame · Up to 1 year

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

Time frame · Up to 3 years

Secondary outcomes

Phase II: Duration of Response (DOR) per investigator

Time frame · Up to 3 years

Phase II: Disease Control Rate (DCR) per investigator

Time frame · Up to 3 years

Phase II: Progression Free Survival (PFS) per investigator

Time frame · Up to 3 years

Phase II: Overall Survival (OS)

Time frame · Up to 3 years

Peak Concentration:Cmax

Time frame · Up to 3 years

Area under the plasma concentration-time curve: AUC

Time frame · Up to 3 years

Half-Life: t1/2

Time frame · Up to 3 years

Phase II: Blood concentrations and PK parameters of sirolimus for injection(albumin bound) and Octreotide long-acting injection.

Time frame · From first dose of treatment to C3D15

Phase II: Changes in serum chromogranin A, 24-hour urinary 5-hydroxyindoleacetic acid, and serum IGF-1 levels from baseline.

Time frame · From first dose of treatment to end of treatment

Phase III: Progression Free Survival (PFS) per investigator

Time frame · Up to 3 years

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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\~2. * 7\. Organ function reserve is good. * 8\. Be able to sign a written informed consent form. Exclusion Criteria: * 1\. 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)\[ Applicable to Phase II dose expansion and Phase III stages\]. * 2\. Has uncontrolled/severe diarrhea or an axillary temperature \> 38.0°C at enrollment. * 3\. Received treatment with other unlisted clinical investigational drugs within 4 weeks prior to the first use of the investigational drug. * 4\. Undergone major surgical procedures within 4 weeks prior to the first use of the investigational drug and have not fully recovered. * 5\. Received systemic use of corticosteroids or other immunosuppressive therapy within 2 weeks prior to the first use of the study drug. * 6\. With an infection that requires systemic anti-infective treatment within 2 weeks prior to the first use of the study drug. * 7\. 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. * 8\. Has a serious history of cardiovascular and cerebrovascular diseases. * 9\. Having active brain metastasis and/or malignant meningitis. * 10\. With a history of severe lung diseases. * 11\. During screening, there may be symptomatic gallstones or a history of symptomatic gallstones but no surgical treatment has been performed. * 12\. Abnormal thyroid function during screening. * 13\. Known to have hypersensitivity reactions or intolerance to any component of all investigational drugs or their excipients. * 14\. Active hepatitis B, active hepatitis C virus infection, or active syphilis infection. * 15\. 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 locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Octreotide.

Related PeptideStat pages

Put the record in context.

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