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Recruiting nowAges 18 Years and up

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

Sponsor: Xinhua Zhang, MD · NCT05464875 on ClinicalTrials.gov ↗

Conditions studied

Gastrointestinal Stromal TumorsUnresectable Solid TumorRecurrent Metastatic Malignant Neoplasm

Where it's running1 site

1 international site
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

Inclusion Criteria:

* 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 Criteria:

* 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.

Updated 2025-02-26 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.