Actively Recruiting
Vebreltinib for Advanced or Metastatic CCS
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-09-30
30
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Vebreltinib for Advanced or Metastatic CCS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older, male or female
- ECOG performance status score of 0 to 2
- Histopathologically confirmed unresectable locally advanced or metastatic clear cell sarcoma
- Previous surgery, radiotherapy, or chemotherapy allowed; PD1/PDL1 use for 4 months without effect allowed to continue
- At least one measurable lesion by RECIST 1.1 criteria
- Normal major organ function with specific hematology, biochemistry, coagulation, cardiac, and thyroid function criteria within 7 days before treatment
- Male or female of childbearing potential must agree to reliable contraception during treatment and for 12 months after last drug dose
- Consent to sign informed consent and comply with study follow-up
You will not qualify if you...
- Previous treatment with class Ib MET inhibitors or cabozantinib
- Clear cell sarcoma only involving bone lesions without soft tissue mass
- Received other antitumor therapy within 4 weeks before enrollment, including systemic therapy, radiotherapy, major surgery, or other clinical trials
- Not recovered from previous treatment adverse events above grade 1 except alopecia
- Significant bleeding risk including tumor invasion of major vessels, recent major surgery, bleeding disorders, or use of anticoagulant therapies (with exceptions for low-dose prophylactic agents)
- Uncontrolled hypertension or poor control with 1-2 antihypertensive drugs
- Poorly controlled diabetes (fasting blood glucose >10 mmol/L)
- Significant cardiovascular disease including unstable angina, recent thromboembolic events, serious arrhythmias, or QTc prolongation
- Liver cirrhosis, active or chronic hepatitis requiring therapy
- Proteinuria ≥2+ or 24-hour urine protein >1g
- Renal failure requiring dialysis
- Immunodeficiency including HIV, history of organ or stem cell transplant, recent immunosuppressive therapy
- Active or uncontrolled severe infection within 4 weeks
- CNS metastases confirmed by imaging
- History of other cancers in past 5 years except certain cured cancers
- History of psychoactive substance abuse or mental disorders
- Recent ascites or pleural effusion drainage or uncontrolled effusions
- Pulmonary fibrosis, interstitial pneumonia, severe COPD
- Severe gastrointestinal diseases such as perforation or active ulcers
- Required use of strong or moderate CYP3A inhibitors or inducers during study
- Use of traditional Chinese medicines with antitumor activity during study
- Anticipated use of systemic or local antitumor therapy during study
- Conditions posing serious risk or confounding study results or affecting ability to complete study
- Multiple factors affecting oral drug administration
- Allergy to study drugs
- Live vaccine administration within 30 days before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
B
Binghao Li, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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