DRUG
Sirolimus for injection (albumin bound)
Sirolimus for injection (albumin bound), ivgtt.
Status
Recruiting
Phase
Phase 2 / Phase 3
Enrollment
298
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Sirolimus for injection (albumin bound), ivgtt.
DRUG
SC
DRUG
Oral, once a day
Timeline
First posted
Sep 10, 2025
Study start
Aug 29, 2025
Primary completion
Aug 29, 2028
Study completion
Aug 29, 2028
Results posted
Not reported
Registry updated
Apr 24, 2026
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
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
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
China. Showing up to 24 locations stored in the fast local snapshot.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Publications
No PMID-linked publications were present in this registry snapshot.
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