Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms

Summary

This is a prospective, multicenter, phase 4, single-arm study designed to evaluate the effectiveness and safety of surufatinib in adult patients with advanced neuroendocrine neoplasms (NENs) treated in routine clinical practice. Approximately 350 patients with histologically or cytologically confirmed advanced NENs and at least one measurable lesion (RECIST 1.1) will receive oral surufatinib, either as monotherapy (300 mg once daily in 4-week cycles) or in combination regimens (250 mg once daily), according to the treating physician's judgment and protocol guidance. Participants will be followed with regular imaging, laboratory tests, cardiac assessments, and patient-reported outcome questionnaires to monitor tumor response, side effects, quality of life, and treatment adherence. The primary outcomes include progression-free survival, objective response rate, disease control rate, and overall survival; safety will be assessed by the type, frequency, and severity of adverse events. The findings are expected to inform standardized, evidence-based use of surufatinib and help optimize individualized treatment strategies for patients with advanced NENs in the real-world setting.

Eligibility

Inclusion Criteria:

* Adequately understand the study and voluntarily sign the Informed Consent Form.
* Have a confirmed histological or cytological diagnosis of neuroendocrine neoplasm.
* Have measurable disease based on RECIST 1.1.
* Have adequate organ and bone marrow function.
* Life expectancy \> 12 weeks.
* Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment.

Exclusion Criteria:

* Other malignant tumors diagnosed within 5 years (excluding effectively treated basal cell carcinoma, cutaneous squamous cell carcinoma, or completely resected in situ cervical/breast cancer).
* Concurrent use of other investigational drugs or approved/investigational anti-tumor therapies.
* Contraindications to surufatinib: active bleeding, ulcers, intestinal perforation/obstruction, uncontrolled hypertension, grade III-IV cardiac insufficiency, \<30 days post-major surgery, or severe hepatic/renal impairment.
* Pregnant (positive pre-treatment pregnancy test) or lactating females.
* Massive pleural effusion/ascites requiring drainage.
* Other diseases/abnormalities (metabolic, physical, or laboratory) deemed by the investigator to preclude study drug use.

Conditions3

Browse More Trials