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RecruitingNCT05464875

A Multicenter Study of Avapritinib Efficacy and Safety of Metastatic or Unresectable Gastrointestinal Stromal Tumors

Sponsor

Xinhua Zhang, MD

Enrollment

74 participants

Start Date

Jul 9, 2022

Study Type

OBSERVATIONAL

Conditions

Unresectable Solid TumorGastrointestinal Stromal TumorsRecurrent Metastatic Malignant Neoplasm

Summary

This is a prospective, multicenter, observational real-world study to explore the therapy patterns and clinical outcomes of Avapritinib in patients with metastatic or unresectable gastrointestinal stromal tumors.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Patients who are aged ≥ 18 years.
  • Gastrointestinal stromal tumors confirmed by histopathological examination, and CD- and/or DOG-1-positive by immunohistochemistry.
  • Presence of mRECIST v1.1-compliant lesions with at least one measurable lesion (non-lymphadenopathy ≥1.0 cm or ≥2-fold scan slice thickness).
  • Treatment with Avapritinib.
  • Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at screening.
  • 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 Criteria3

  • KIT or PDGFRA wild type.
  • Failure to complete continuous atorvastatin for at least 15 days due to intolerability or disease progression.
  • Other serious acute or chronic physical or mental problems, or laboratory abnormalities, may increase the risk associated with participation in the study or use of drugs, or interfere with the judgment of the study results and, in the judgment of the investigator, are not considered appropriate for participation in the investigator.

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Locations(1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

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NCT05464875

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