NCT06431451 The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients with Advanced GISTs
| NCT ID | NCT06431451 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University |
| Condition | Gastrointestinal Stromal Tumors |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a prospective, single-center, observational study to explore the correlation between ripretinib exposure and the efficacy and safety in patients with advanced gastrointestinal stromal tumors
Eligibility Criteria
Inclusion Criteria: * Patients who are aged ≥ 18 years. * Gastrointestinal stromal tumors confirmed by histopathological examination, and CD117 and/or DOG-1-positive by immunohistochemistry. * patients who are currently receiving Ripretinib treatment. * Subjects must have at least one measurable lesion based on mRECIST v1.1 criteria, and have undergone at least one radiographic evaluation for efficacy analysis. * Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 4 * Patient informed consent and signed written consent form. * The patient was compliant and voluntarily scheduled for follow-up, treatment, laboratory tests, and other study procedures. Exclusion Criteria: * Unable to complete at least 15 consecutive days of Ripretinib due to intolerance or disease progression. * Individuals with other serious acute or chronic physical or mental health problems, or abnormal laboratory test results that increase the risk associated with participation in t