Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms
NCT ID: NCT07272512
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
350 participants
INTERVENTIONAL
2025-11-11
2028-11-29
Brief Summary
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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.
Detailed Description
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Approximately 350 patients with histologically or cytologically confirmed advanced NENs and at least one measurable lesion (RECIST 1.1) will be enrolled from multiple centers. According to the treating physician's judgment and protocol guidance, patients will receive oral surufatinib either as monotherapy (300 mg once daily in 4-week cycles) or in combination regimens (250 mg once daily), and treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study. Tumor assessments, laboratory tests, cardiac monitoring, and patient-reported outcome questionnaires (including generic and NET-specific quality-of-life scales and a medication-adherence scale) will be performed at regular intervals during follow-up. The study will estimate progression-free survival, objective response rate, disease control rate, and overall survival, describe the incidence and severity of treatment-emergent adverse events, and explore how baseline clinicopathological features and treatment patterns are associated with outcomes, with the aim of developing evidence-based, standardized, and individualized clinical pathways for the real-world use of surufatinib in advanced NENs.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Surufatinib
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.
Interventions
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Surufatinib
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Locations
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Huadong Hospital Affiliated to Fudan University
Shanghai, , China
Huashan Hospital Affiliated to Fudan University
Shanghai, , China
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, , China
Shanghai General Hospital shanghai jiao tong university school of medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Chongyi Jiang
Role: primary
Deliang Fu
Role: primary
Xiuying Xiao
Role: primary
Jiang Long
Role: primary
Other Identifiers
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HMPL-012-SPRING-NEN116
Identifier Type: -
Identifier Source: org_study_id