Surufatinib for adults with advanced neuroendocrine neoplasms in routine care
Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms
This study will see if daily oral surufatinib, given alone or with other treatments, helps adults with advanced neuroendocrine tumors when used in regular clinical practice.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Drugs / interventions | surufatinib |
| Locations | 4 sites (Shanghai and 3 other locations) |
| Trial ID | NCT07272512 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with confirmed advanced neuroendocrine neoplasms who have at least one measurable lesion by RECIST 1.1, adequate organ and marrow function, and a life expectancy greater than 12 weeks are ideal candidates.
Not a fit: Patients with contraindications to surufatinib (for example active bleeding, uncontrolled hypertension, recent major surgery, severe hepatic or renal impairment), pregnant individuals, or those receiving conflicting investigational therapies are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, surufatinib could prolong disease control and help maintain or improve quality of life for people with advanced neuroendocrine neoplasms.
How similar studies have performed: Surufatinib has demonstrated clinically meaningful efficacy in prior phase 3 trials for both pancreatic and extra‑pancreatic NETs, and this phase 4 work aims to characterize its real-world use.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.