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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

Gastrointestinal Stromal Tumors

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)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

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NCT06431451

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