Using Avapritinib for treating specific types of gastrointestinal stromal tumors

Avapritinib in the Treatment of Unresectable or Recurrent Metastatic Gastrointestinal Stromal Tumors Non-exon18 Mutations of PDGFRA:A Real-world Study

This study is testing if Avapritinib can help people with hard-to-treat gastrointestinal stromal tumors that have specific gene mutations feel better and live longer.

Quick facts

• Study type: Observational
• Enrollment: 74 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University (other)
• Drugs / interventions: Avapritinib, Repaitinib, imatinib, sunitinib
• Locations: 1 site (Guangzhou)
• Trial ID: NCT05461664 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of Avapritinib in patients with unresectable or recurrent metastatic gastrointestinal stromal tumors (GIST) that have non-exon18 mutations of the PDGFRA gene. It involves multiple centers and focuses on real-world outcomes for patients who have been treated with Avapritinib. The study will assess tumor response and patient survival, providing insights into the drug's impact on this specific patient population. Participants will be monitored for their treatment progress and any associated side effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed GIST and specific PDGFRA mutations who are receiving Avapritinib.

Not a fit: Patients with wild-type KIT or PDGFRA mutations or those unable to tolerate the treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the effectiveness of Avapritinib for patients with specific GIST mutations, potentially improving treatment options.

How similar studies have performed: Other studies have shown promising results with targeted therapies for GIST, suggesting that this approach may yield beneficial outcomes.

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.

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

Conditions: Gastrointestinal Stromal Tumors, Unresectable Solid Tumor, Recurrent Metastatic Malignant Neoplasm, Avapritinib, Genetic testing