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

Launched by XINHUA ZHANG, MD · Jul 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Avapritinib for patients with metastatic or unresectable gastrointestinal stromal tumors (GISTs), which are a type of cancer that affects the digestive system. The goal is to understand how well this treatment works and its safety in real-world settings. The study is currently recruiting participants who are at least 18 years old and have confirmed GISTs that meet specific criteria.

To be eligible for the trial, patients must have measurable tumors and a good performance status, meaning they can carry out daily activities with minimal issues. Participants will receive Avapritinib and will be asked to attend regular follow-up appointments for tests and monitoring. It’s important to know that this study is looking for patients who have certain characteristics and who are willing to commit to the study procedures. If you or someone you know is dealing with this type of cancer and might be interested, speaking with a healthcare provider can provide more information about participating in the trial.

Gender

ALL

Eligibility criteria

• 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.