Metastatic or surgically unresectable neuroendocrine tumors
Conditions
Interventions
Experimental Group:Surufatinib in Combination with Octreotide Microspheres
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. Patients histologically or cytologically confirmed as having neuroendocrine tumors (G1-3), who are either surgically unresectable or have distant metastasis, and have measurable lesions (meeting RECIST 1.1 criteria), with the exception of having only one measurable lymph node lesion. 3. Patients who have not received prior systemic chemotherapy, targeted therapy, or endocrine therapy for advanced disease (except for those with disease recurrence more than 12 months after prior surgery, chemotherapy, targeted therapy, or immunotherapy, who are eligible for enrollment). 4. ECOG performance status 0-1, with an expected survival of >=3 months; patients must have an indication for systemic treatment and no contraindications to such treatment. 5. The patient is able to understand and provide written informed consent (if the patient lacks the capacity to consent, the consent must be provided by their legally authorized representative).
Exclusion criteria
Exclusion criteria: 1. Patients with a pathological diagnosis of neuroendocrine carcinoma, including but not limited to carcinoid tumor, atypical carcinoid, small cell lung cancer, etc. 2. Have received prior treatment with other anti-angiogenic TKI drugs and/or octreotide; or have undergone any approved or investigational systemic anti-tumor therapies within 4 weeks prior to enrollment, including but not limited to: chemotherapy, radical radiotherapy, biotherapy/immunotherapy, targeted therapy, and traditional Chinese medicine therapy. (Note: Patients who have received traditional Chinese medicine with explicitly approved anti-tumor indications may still be eligible after a 1-week washout period.); 3. Have participated in another clinical trial of drug(s) not yet approved or marketed in China within 4 weeks prior to enrollment and have received the corresponding experimental drug treatment. 4. Have undergone any major surgery or significant invasive procedure (excluding minor procedures such as venous catheter placement and puncture drainage) within 4 weeks prior to enrollment, in the judgment of the investigator. 5. Patients with a history of or concurrent other malignancies, with the exception of cured basal cell carcinoma of the skin or carcinoma in situ of the cervix. 6. Have received systemic treatment with traditional Chinese patent medicines with approved anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin) within 2 weeks prior to dosing, with the exception of local use for the control of pleural effusion. 7. Have a history of active autoimmune disease that required systemic therapy (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are not considered a form of systemic therapy. 8. Are receiving systemic corticosteroid therapy (excluding topical administration via routes such as intranasal, inhaled, or other local applications) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. Note: The use of physiologic doses of corticosteroids (e.g., =10 mg/day of prednisone or equivalent) is permitted. 9. Have undergone allogeneic organ transplant (with the exception of corneal transplant) or allogeneic hematopoietic stem cell transplant. 10. Have a known history of hypersensitivity to Surufatinib, or to the active ingredients or excipients of Octreotide microspheres. 11. Have a known history of active central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal disease). 12. Have a known history of hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders, thrombocytopenia, hypersplenism) OR have experienced arterial or venous thrombotic events within 6 months prior to the first dose, or are currently receiving thrombolytic or anticoagulant therapy. 13. Have a known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV-1/2 antibodies); OR have untreated active hepatitis B, defined as positive for HBsAg with detectable HBV-DNA levels above the upper limit of normal (ULN) as per the central laboratory of the participating study site. 14. Have active hepatitis C virus (HCV) infection, defined as being HCV antibody positive with detectable HCV-RNA levels above the lower limit of detection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Disease Control Rate (DCR);Safety;Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactDongyuan Zhu
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed