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Vebreltinib for Advanced or Metastatic CCS

NCT07153887 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-30

No results posted yet for this study

Summary

This is a prospective, cohort, multicenter study. Cohort 1 is treatment group. All eligible subjects will receive Vebreltinib (200 mg bid po) after signing the informed consent and meeting the inclusion/exclusion criteria, until disease progression, intolerable toxicity, or death. Subjects will undergo MET abnormality testing after enrollment, including MET amplification or MET protein overexpression.

Cohort 2 is external reference group. Subjects diagnosed with CCS and met the inclusion criteria but refused to enter Cohort1 will receive the standard treatment decided by investigators. These subjects will receive follow-up. The efficacy and safety data will be collected.

Imaging evaluation will be performed using RECIST v1.1, with CT or MR plain scans every two months (±7 days) until disease recurrence or death.

During the study, subjects will receive safety follow-up, and survival follow-up will be conducted every two months after treatment, which can be done by telephone interview for approximately 3 years after treatment ends.

Conditions

  • Clear Cell Sarcoma (CCS)

Interventions

DRUG

Vebreltinib

Vebreltinib： Oral capsule formulation, specification: 100 mg/capsule. Subjects will start medication after enrollment, 200 mg bid po, until disease progression, intolerable toxicity, or death. If disease progression is observed in the first evaluation (2 months after the first administration), if the investigator deems it possible to continue benefiting from targeted therapy, targeted therapy combined with best supportive care can be continued until the second evaluation (4 months).

OTHER

Standard medical treatment

standard treatment like chemotherapy, PD1, Anlotinib……

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-07-15
Completion
2027-07-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07153887 on ClinicalTrials.gov