Actively Recruiting
Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors
Led by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Updated on 2026-04-24
298
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unresectable locally advanced or metastatic G1/G2 gastroenteropancreatic neuroendocrine tumors diagnosed by histology according to 2019 WHO grading criteria
- Presence of poor prognostic factors
- Non-functional gastroenteropancreatic neuroendocrine tumors
- At least one evaluable lesion meeting RECIST V1.1 criteria (phase II safety run-in stage only)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Good organ function reserve
- Ability to sign a written informed consent form
You will not qualify if you...
- Previous treatment with somatostatin receptor-targeted therapies (including somatostatin analogs and peptide receptor radionuclide therapy) or mTOR inhibitors, except certain cases in phase II dose expansion and phase III
- Uncontrolled or severe diarrhea or axillary temperature above 38.0°C at enrollment
- Use of other investigational drugs within 4 weeks prior to study drug
- Major surgery within 4 weeks prior to study drug without full recovery
- Systemic corticosteroids or immunosuppressive therapy within 2 weeks prior to study drug
- Active infection requiring systemic anti-infective treatment within 2 weeks prior to study drug
- Use or need for strong CYP3A4 enzyme inhibitors or inducers within 2 weeks prior to study drug
- Serious history of cardiovascular or cerebrovascular diseases
- Active brain metastasis or malignant meningitis
- History of severe lung diseases
- Symptomatic gallstones or untreated history of symptomatic gallstones
- Abnormal thyroid function during screening
- Known hypersensitivity or intolerance to study drugs or excipients
- Active hepatitis B, hepatitis C virus, or syphilis infection
- History of autoimmune diseases (excluding tuberous sclerosis), immunodeficiency including HIV positive, or organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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