Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms
Recruiting now · Phase 4
Conditions studied: Neuroendocrine Tumors, Neuroendocrine Neoplasms
In brief
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.
Key facts
- Study ID
- NCT07272512
- Run by
- Shanghai Zhongshan Hospital
- People needed
- 350
- Starts
- 2025-11-11
- Expected to finish
- 2028-11-29
- Last updated by the study team
- 2025-12-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Huadong Hospital Affiliated to Fudan University — Shanghai, China (enrolling)
- Huashan Hospital Affiliated to Fudan University — Shanghai, China (enrolling)
- Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, China (enrolling)
- Shanghai General Hospital shanghai jiao tong university school of medicine — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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