NCT07272512RecruitingPhase 4
Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 27 Nov 2025
- Start date
- 11 Nov 2025
- Primary completion date
- 29 Nov 2027
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT07272512
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 350
- From 11 Nov 2025 to the primary completion date, 29 Nov 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of other investigational drugs or approved/investigational anti-tumor therapies.
Other illness
- 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).
- 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.
Lab values
- Other diseases/abnormalities (metabolic, physical, or laboratory) deemed by the investigator to preclude study drug use.
Other
- Pregnant (positive pre-treatment pregnancy test) or lactating females.
- Massive pleural effusion/ascites requiring drainage.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Huashan Hospital Affiliated to Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Huadong Hospital Affiliated to Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.