Gastrointestinal Stromal Tumors.
Margaret von Mehren, Heikki Joensuu
https://pubmed.ncbi.nlm.nih.gov/29220298Actively Recruiting
Led by Xinhua Zhang, MD · Updated on 2025-02-26
74
Participants Needed
1
Research Sites
N/A
Total Duration
X
Xinhua Zhang, MD
Lead Sponsor
P
Peking University Cancer Hospital & Institute
Collaborating Sponsor
Researchers are exploring the use of Avapritinib therapy in patients with gastrointestinal stromal tumors (GIST) that have non-exon18 mutations of the PDGFRA gene. GISTs are common tumors in the gastrointestinal tract that vary from benign to malignant and often involve mutations in the KIT or PDGFRA genes. This study aims to understand the benefits of Avapritinib beyond the PDGFRA exon18 mutation and to investigate resistance mutations that affect treatment outcomes in advanced GISTs. This is a prospective, multicenter, observational real-world study focusing on patients with unresectable or recurrent metastatic GIST who have non-exon18 PDGFRA mutations and are treated with Avapritinib. Participants receive Avapritinib therapy as part of their routine care, and the study observes their responses and mutation changes over time. The study does not involve randomization or placebo groups but monitors participants under real-world conditions. Participants will undergo regular follow-up visits for clinical evaluation, imaging tests compliant with mRECIST v1.1 criteria, laboratory assessments, and recording of adverse events over two years. Researchers will measure outcomes such as objective response rate, clinical benefit rate, duration of response, progression-free survival, overall survival, and treatment-related safety events. The study emphasizes ongoing monitoring to provide evidence for personalized treatment approaches in advanced GIST patients.
CONDITIONS
Avapritinib in the Treatment of Unresectable or Recurrent Metastatic GIST Non-exon18 Mutations of PDGFRA
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants who are currently receiving Avapritinib treatment are observed to assess the effectiveness and safety of the medication.
Regular visits to monitor treatment response and adverse events
Total: 1 location
1
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China, 510080
Actively Recruiting
X
Xinhua Zhang, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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