NCT05461664 Avapritinib in the Treatment of Unresectable or Recurrent Metastatic GIST Non-exon18 Mutations of PDGFRA
| NCT ID | NCT05461664 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xinhua Zhang, MD |
| Condition | Gastrointestinal Stromal Tumors |
| Study Type | OBSERVATIONAL |
| Enrollment | 74 participants |
| Start Date | 2022-07-10 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 74 participants in total. It began in 2022-07-10 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, multicenter, observational real-world study to explore the Avapritinib therapy in GIST patients who definited Non-exon18 Mutations of PDGFRA.
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.
Contact & Investigator
Xinhua Zhang, PhD
PRINCIPAL INVESTIGATOR
First affiliated hosptial,Sun Yat-sen university
Frequently Asked Questions
Who can join the NCT05461664 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Stromal Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05461664 currently recruiting?
Yes, NCT05461664 is actively recruiting participants. Contact the research team at zhangxinhua@mail.sysu.edu.cn for enrollment information.
Where is the NCT05461664 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05461664 clinical trial?
NCT05461664 is sponsored by Xinhua Zhang, MD. The principal investigator is Xinhua Zhang, PhD at First affiliated hosptial,Sun Yat-sen university. The trial plans to enroll 74 participants.