Surufatinib for adults with advanced neuroendocrine neoplasms in routine care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm, open-label phase 4 study enrolling about 350 adults with histologically or cytologically confirmed advanced neuroendocrine neoplasms and measurable disease. Participants receive oral surufatinib as monotherapy (300 mg once daily) or in combination regimens (250 mg once daily) per treating physician judgment, with treatment continued until progression or unacceptable toxicity. Regular imaging, laboratory tests, cardiac monitoring, and patient-reported outcome questionnaires will track tumor response, adverse events, quality of life, and treatment adherence. Primary endpoints include progression-free survival, objective response rate, disease control rate, overall survival, and a comprehensive safety assessment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Huadong Hospital Affiliated to Fudan University
  Shanghai, China Recruiting
• Huashan Hospital Affiliated to Fudan University
  Shanghai, China Recruiting
• Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
  Shanghai, China Recruiting
• Shanghai General Hospital shanghai jiao tong university school of medicine
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Wenquan Wang, M.D. Ph.D
• Email: wang.wenquan@zs-hospital.sh.cn
• Phone: +86 21 31587861

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• Hypofractionated chemoradiotherapy with tislelizumab and surufatinib for unresectable stage III NSCLC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.