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Neoadjuvant Imatinib in High-Risk GIST (ZJGIST-01)
NCT04933669Phase 2
Key facts
- Status
- Recruiting
- Start
- Sep 2021
- Primary completion
- Dec 2029
- Countries
- 1
- Sponsor
- First Affiliated Hospital, Zhejiang University School of Medicine
- Modality
- Small Molecules
- Drugs
- imatinib
- Conditions
- gastrointestinal stromal tumor (GIST)
01
Overview
Phase 2, open-label, single-arm trial of imatinib in gastrointestinal stromal tumor (GIST), sponsored by First Affiliated Hospital, Zhejiang University School of Medicine. Primary endpoint: Progression-Free Survival at 5 years. Started Sep 2021; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Imatinib neoadjuvant
Sequential neoadjuvant imatinib, surgery, and adjuvant imatinib.
03
Who it enrols
Adults with high-risk primary GIST (c-Kit/DOG-1 positive) with specific mutations (excluding D842V, exon 9, or wild type) and no prior TKI treatment.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Overall Survival
Objective Response Rate
R0 resection rate
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