Actively Recruiting
Clinical Research of Drug Holiday Based on MRD Detection in GIST Patients at High Risk of Recurrence
Led by Peking University People's Hospital · Updated on 2023-05-31
40
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is aimed: * to evaluate the dynamic monitoring value of MRD detection for postoperative recurrence in high-risk GIST patients; * to evaluate the effect of drug holiday mode based on MRD detection on progression-free Survival (PFS) and/or overall survival (OS) after drug withdrawal for high-risk GIST patients who have achieved disease control after long-term use of imatinib; ③ to investigate the response rate of imatinib re-use in patients who developed disease progression after drug withdrawal; ④ to explore whether the "drug holiday" treatment mode based on MRD detection could delay the occurrence of secondary imatinib resistance mutations for high-risk GIST patients with long-term use of imatinib after surgery.
CONDITIONS
Official Title
Clinical Research of Drug Holiday Based on MRD Detection in GIST Patients at High Risk of Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Primary and metastatic lesions underwent R0 or R1 surgical removal with clinical diagnosis of high-risk GIST
- Received imatinib treatment for 3 years after surgery with no gross lesions on imaging and doctor considering drug withdrawal
- Negative baseline circulating tumor DNA (ctDNA) liquid biopsy
- No primary imatinib-resistant mutations detected by genetic testing, including SDH-deficient, NF1-mutant, BRAF-mutant, or NTRK3 rearrangement
- Performance status score of 0-1 and expected survival longer than 4 months
- Willing to stop drug use, understand the study, provide informed consent, cooperate with follow-up and testing, and allow use of data for research and product development
You will not qualify if you...
- Surgical tumor tissue (fresh or paraffin) not available
- Not receiving assigned treatment or changed therapy before disease progression
- Unable to follow study schedule for follow-up
- Unable to undergo or provide required imaging assessments
- Other conditions judged by investigators as unsuitable for enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
Z
Zhidong Gao, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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