Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms

NCT07272512 | Recruiting Phase 4

• 1 other identifier: HMPL-012-SPRING-NEN116
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 4

Brief Summary

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

Neuroendocrine Neoplasms; Neuroendocrine Tumors

Keywords

surufatinib; advanced neuroendocrine tumors; advanced neuroendocrine neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  From the date of enrollment to the date of the first onset of disease progression or death from any cause, whichever comes first.

  up to 12 months

Secondary Outcomes (3)

• Objective response rate (ORR)

  up to 12 months

• Disease control rate (DCR)

  up to 12 months

• Overall survival (OS)

  up to 36 months

Study Arms (1)

Surufatinib Treatment

EXPERIMENTAL

Adult patients with histologically or cytologically confirmed advanced neuroendocrine neoplasms (NENs) will receive oral surufatinib according to routine clinical practice and protocol guidance. Surufatinib will be administered either as monotherapy (300 mg once daily in continuous 4-week cycles) or as part of combination therapy (250 mg once daily) at the discretion of the treating physician. Treatment will continue until radiologic or clinical disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study, whichever occurs first. Concomitant anticancer therapies, dose modifications, and interruptions are permitted and will be managed in accordance with the protocol and local standard of care.

Drug: Surufatinib

Interventions

Surufatinib DRUG

Surufatinib (Sulanda, HMPL-012) is an oral small-molecule tyrosine kinase inhibitor that selectively targets VEGFR1-3, FGFR1 and CSF1R, exerting both anti-angiogenic and immune-modulating effects. In this study, surufatinib will be administered as film-coated tablets once daily: 300 mg QD for monotherapy or 250 mg QD when used in combination regimens, according to protocol guidance and the treating physician's judgment. Treatment is given in continuous 4-week cycles and continued until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study. Dose interruptions and reductions are allowed and will be managed following the protocol and the approved prescribing information.

Surufatinib Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (4)

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

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

surufatinib

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Central Study Contacts

Wenquan Wang, M.D. Ph.D

CONTACT

+86 21 31587861; wang.wenquan@zs-hospital.sh.cn

Xu Han, M.D. Ph.D

CONTACT

+86 21 31587861; han.xu1@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study; no masking is implemented for any study personnel or participants.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective multicenter phase 4, single-group assignment, open-label study of surufatinib in patients with advanced neuroendocrine neoplasms

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): November 29, 2027
• Study Completion (Estimated): November 29, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)