Evaluating Avapritinib for Advanced Gastrointestinal Stromal Tumors
A Multicenter Study of Avapritinib Efficacy and Safety of Metastatic or Unresectable Gastrointestinal Stromal Tumors
This study is testing if Avapritinib can help people with advanced gastrointestinal stromal tumors feel better and improve their health in real-world situations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Drugs / interventions | Avapritinib, Imatinib, Sunitinib |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT05464875 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to assess the efficacy and safety of Avapritinib in patients with metastatic or unresectable gastrointestinal stromal tumors (GISTs). It will analyze therapy patterns and clinical outcomes in real-world settings, focusing on patients who have confirmed GISTs and are treated with Avapritinib. The study will include patients aged 18 and older with measurable lesions and an ECOG performance status of 0 to 2. By gathering data from multiple centers, the study seeks to provide insights into the effectiveness of this targeted therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed GISTs who are receiving Avapritinib.
Not a fit: Patients with wild-type KIT or PDGFRA mutations or those unable to tolerate treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and survival rates for patients with advanced GISTs.
How similar studies have performed: Previous studies have shown promising results with targeted therapies for GISTs, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, China (Recruiting)
Study contacts
- Principal investigator: Xinhua Zhang, PhD — First affiliated hosptial,Sun Yat-sen university
- Study coordinator: Xinhua Zhang, PhD
- Email: zhangxinhua@mail.sysu.edu.cn
- Phone: +8620-87332200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.