A Multicenter Study of Avapritinib Efficacy and Safety of Metastatic or Unresectable Gastrointestinal Stromal Tumors
Recruiting now
Conditions studied: Gastrointestinal Stromal Tumors, Unresectable Solid Tumor, Recurrent Metastatic Malignant Neoplasm
In brief
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.
Key facts
- Study ID
- NCT05464875
- Run by
- Xinhua Zhang, MD
- People needed
- 74
- Starts
- 2022-07-09
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-02-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, China (enrolling)
Full record on ClinicalTrials.gov
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