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

Exclusion Criteria15

• \. 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)\[ Applicable to Phase II dose expansion and Phase III stages\].
• \. Has uncontrolled/severe diarrhea or an axillary temperature > 38.0°C at enrollment.
• \. Received treatment with other unlisted clinical investigational drugs within 4 weeks prior to the first use of the investigational drug.
• \. Undergone major surgical procedures within 4 weeks prior to the first use of the investigational drug and have not fully recovered.
• \. Received systemic use of corticosteroids or other immunosuppressive therapy within 2 weeks prior to the first use of the study drug.
• \. With an infection that requires systemic anti-infective treatment within 2 weeks prior to the first use of the study drug.
• \. 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.
• \. Has a serious history of cardiovascular and cerebrovascular diseases.
• \. Having active brain metastasis and/or malignant meningitis.
• \. With a history of severe lung diseases.
• \. During screening, there may be symptomatic gallstones or a history of symptomatic gallstones but no surgical treatment has been performed.
• \. Abnormal thyroid function during screening.
• \. Known to have hypersensitivity reactions or intolerance to any component of all investigational drugs or their excipients.
• \. Active hepatitis B, active hepatitis C virus infection, or active syphilis infection.
• \. 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.