RecruitingNCT06431451
The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients with Advanced GISTs
The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients with Advanced Gastrointestinal Stromal Tumors: an Observational Study
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Enrollment
60 participants
Start Date
Jun 1, 2024
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria2
- 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 the study or use of the drug, or that could interfere with the interpretation of study results, and who, in the opinion of the investigator, are not suitable for participation in the study.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06431451
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