Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Surufatinib
DrugSurufatinib (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.
Treatment groups
350 Participants
are divided into 1 treatment groupGroup A: Surufatinib TreatmentExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
up to 12 monthsSecondary outcomes
1
Objective response rate (ORR)
CR + PR rate according to the RECIST version 1.1 guidelines.
Time frame
up to 12 months2
Disease control rate (DCR)
CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Time frame
up to 12 months3
Overall survival (OS)
From the date of enrollment to the date of the first onset of death from any cause
Time frame
up to 36 monthsSponsors and contacts
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Source ClinicalTrials.gov