Actively Recruiting
Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms
Led by Shanghai Zhongshan Hospital · Updated on 2025-12-19
350
Participants Needed
4
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and sign the Informed Consent Form voluntarily
- Have a confirmed diagnosis of neuroendocrine neoplasm by histology or cytology
- Have measurable disease according to RECIST 1.1 criteria
- Have adequate organ and bone marrow function
- Have a life expectancy longer than 12 weeks
- Women of childbearing age agree to use effective contraception during treatment
You will not qualify if you...
- Diagnosed with other malignant tumors within the past 5 years except treated basal cell carcinoma, skin squamous cell carcinoma, or fully removed in situ cervical/breast cancer
- Using other investigational or approved anti-tumor therapies concurrently
- Have contraindications to surufatinib such as active bleeding, ulcers, intestinal blockage or perforation, uncontrolled high blood pressure, severe heart failure (grade III-IV), recent major surgery within 30 days, or serious liver/kidney problems
- Are pregnant or breastfeeding
- Have large pleural effusion or ascites needing drainage
- Have other medical conditions judged by the investigator to prevent use of the study drug
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Huadong Hospital Affiliated to Fudan University
Shanghai, China
Actively Recruiting
2
Huashan Hospital Affiliated to Fudan University
Shanghai, China
Actively Recruiting
3
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
Actively Recruiting
4
Shanghai General Hospital shanghai jiao tong university school of medicine
Shanghai, China
Actively Recruiting
Research Team
W
Wenquan Wang, M.D. Ph.D
CONTACT
X
Xu Han, M.D. Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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