Status:
RECRUITING
Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Gastroenteropancreatic Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 29 2028
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT07165886
Start Date
August 29 2025
End Date
August 29 2028
Last Update
September 10 2025
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China