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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vebreltinib Arm | Experimental | subjects will receive Vebreltinib (200 mg bid po) , until disease progression, intolerable toxicity, or death. Subjects will undergo MET abnormality testing after enrollment, including MET amplification or MET protein overexpression. |
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| External reference arm | Other | Subjects diagnosed with CCS and met the inclusion criteria but refused to enter Cohort1 will receive the standard treatment decided by investigators. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vebreltinib | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate. ORR is defined as the proportion of patients who achieve partial response (PR), or complete response (CR) among all patients. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| DCR | DCR is defined as the proportion of patients who achieve stable disease (SD), partial response (PR), or complete response (CR) among all patients. | up to 24 months |
| PFS | Progression-free survival, is defined as the length of time (months) from randomization to any of the following events: any progression of disease based on response evaluation criteria in solid tumors (RECIST) 1.1, or death due to any cause. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Binghao Li, PHD | Contact | 0571-87783777 | libinghaohz@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42376809 | Derived | Jiang Y, Lin N, Huang X, Yan X, Liu M, Qu H, Li X, Lin P, Li H, Ye Z, Li B. VEBrant: a multicenter, phase II study of MET inhibitor vebreltinib combined with PD-1-based immunotherapy in advanced clear cell sarcoma. Future Oncol. 2026 Jun 30:1-7. doi: 10.1080/14796694.2026.2695212. Online ahead of print. |
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| ID | Term |
|---|---|
| D018227 | Sarcoma, Clear Cell |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Standard medical treatment | Other | standard treatment like chemotherapy, PD1, Anlotinib…… |
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| up to 24 months |
| OS | overall survival, is defined as the time (months) from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. | up to 24 months |
| 12m-OSR | 12-month overall survival rate. OS is defined as the time (months) from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. | up to 12 months |
| DOR | Duration of response, is defined as the time (months) from partial response to progression of disease. | up to 24 months |
| Treatment-related adverse event (TRAE) | Numbers of participants with treatment-related adverse events as assessed by CTCAEv5.0 | up to 24 months |
| D012509 | Sarcoma |