Albumin‑bound sirolimus plus long‑acting octreotide for metastatic gastroenteropancreatic neuroendocrine tumors

Phase II/III Study to Evaluate the Safety and Efficacy of Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

This test will see if combining albumin‑bound sirolimus with long‑acting octreotide helps people with unresectable or recurrent non‑functional GEP‑NETs who have poor prognostic factors.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 298 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07165886 on ClinicalTrials.gov

What this trial studies

This interventional Phase II/III program begins with a Phase II safety run‑in and proceeds to later‑phase evaluation of treatment efficacy. The planned regimen pairs albumin‑bound sirolimus with octreotide long‑acting injection, and everolimus is also listed among the interventions. Eligible patients are adults with unresectable or recurrent non‑functional G1/G2 GEP‑NETs with poor prognostic features, ECOG 0–2, and adequate organ function, with at least one RECIST v1.1‑measurable lesion required for the Phase II safety run‑in. The trial is led by CSPC ZhongQi Pharmaceutical Technology and is conducted at Chinese PLA General Hospital in Beijing.

Who should consider this trial

Good fit: Adults with unresectable or recurrent non‑functional G1/G2 gastroenteropancreatic neuroendocrine tumors who have poor prognostic factors, ECOG performance status 0–2, good organ function, and (for the Phase II run‑in) at least one measurable lesion are the intended candidates.

Not a fit: Patients who have previously received SSTR‑targeted therapies or mTOR inhibitors (except certain adjuvant SSA cases), those with functional tumors, uncontrolled severe diarrhea or fever, or inadequate organ function are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could slow tumor progression and provide an additional treatment option for patients with unresectable or recurrent non‑functional GEP‑NETs.

How similar studies have performed: mTOR inhibitors such as everolimus and somatostatin analogs individually have shown benefit in GEP‑NETs, but combining albumin‑bound sirolimus with octreotide is a newer approach with limited existing data.

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\. 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.

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Clinical Trials Information Group officer

Conditions Gastroenteropancreatic Neuroendocrine Tumors