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

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT07272512
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Dec 9, 2025
Start date
Nov 11, 2025
Status verified
Nov 2025
Primary completion
Nov 29, 2027
Completion
Nov 29, 2028

Study Design

Enrollment
350 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Surufatinib Treatment
    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.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: up to 12 months ]

Central Contacts

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