Vebreltinib for Advanced or Metastatic CCS

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.

NCT Number	NCT07153887
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions	Clear Cell Sarcoma (CCS)
Enrollment	30 participants
Start Date	2025-09-30
Primary Completion	2026-07-15 (estimated)
Study Completion	2027-07-15 (estimated)
Updated on ClinicalTrials.gov	2025-09-30