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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of surufatinib in adults with advanced neuroendocrine neoplasms (NENs) in a prospective, multicenter, phase 4, single-arm study. Surufatinib is an oral drug with anti-angiogenic and immune-modulating effects, previously shown to have meaningful clinical activity. This study aims to gather real-world evidence on surufatinib's use, safety, and impact on quality of life in patients with confirmed advanced NENs who have measurable disease. Participants will receive surufatinib orally either as monotherapy (300 mg once daily in continuous 4-week cycles) or in combination regimens (250 mg once daily) based on the treating physician's judgment and study guidelines. Treatment continues until disease progression, unacceptable side effects, withdrawal, death, or study end. The study allows dose adjustments and use of other anticancer therapies as needed. Follow-up includes regular imaging, lab tests, cardiac monitoring, and patient questionnaires. During the study, researchers will assess tumor response, side effects, quality of life, and treatment adherence. Key outcomes measured include progression-free survival, objective response rate, disease control rate, and overall survival. Safety is monitored through adverse event tracking. Patients will be followed for up to 36 months to collect these data and to help guide future individualized treatment strategies with surufatinib in real-world clinical practice.
CONDITIONS
Brief 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 voluntarily agree to participate by signing informed consent
- Have a confirmed diagnosis of neuroendocrine neoplasm by tissue examination
- 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 potential must agree to use effective contraception during treatment
You will not qualify if you...
- Diagnosed with other malignant tumors within the past 5 years except certain treated skin or cervical/breast cancers
- Using other investigational or approved anti-tumor drugs concurrently
- Have conditions that contraindicate surufatinib such as active bleeding, ulcers, intestinal blockage, uncontrolled high blood pressure, severe heart failure, recent major surgery, or severe liver/kidney problems
- Are pregnant or breastfeeding
- Have large fluid buildup in chest or abdomen needing drainage
- Have other medical conditions or lab abnormalities that make study drug use unsafe as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months or until disease progression or discontinuation
Participants receive oral surufatinib as monotherapy or in combination regimens in continuous 4-week cycles according to their physician's guidance. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
Regular visits for treatment monitoring and assessments during treatment cycles
Duration - Up to 36 months
Participants undergo tumor assessments, laboratory tests, cardiac monitoring, and complete quality-of-life and medication adherence questionnaires at regular intervals during follow-up to monitor outcomes and safety.
Regular visits for ongoing assessments
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
X
Xu Han, M.D. Ph.D
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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