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RECRUITING
NCT07153887
PHASE2

Vebreltinib for Advanced or Metastatic CCS

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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.

Official title: An Exploratory Clinical Trial of Vebreltinib for the Treatment of Patients With Locally Advanced or Metastatic Clear Cell Sarcoma

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-09-30

Completion Date

2027-07-15

Last Updated

2025-09-30

Healthy Volunteers

No

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……

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China