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

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.