Clinical Research of Drug Holiday Based on MRD Detection in GIST Patients at High Risk of Recurrence
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * ① Age: ≥18 years and ≤75 years; * ② The primary lesion (and metastatic lesion) underwent R0 or R1 surgical resection, and patients were clinically diagnosed with high recurrence risk GIST combined with postoperative pathological results; * ③ The patient have received imatinib adjuvant therapy for 3 years after surgery, and no gross lesions were detected by imaging examination, and the possibility of drug withdrawal was considered based on the comprehensive judgment of the doctor in charge; * ④ The liquid biopsy for baseline ctDNA is negative; * ⑤ Primary Imatinib resistant mutations were not detected by genetic testing, such as SDH-deficient GIST, NF1-mutant GIST, BRAF-mutant GIST and GIST with NTRK3 rearrangement; * ⑥ PS score is 0-1 and expected survival time is more than 4 months; * ⑦ Patients are willing to stop drug use and observe, and patients and their families could understand the study protocol and voluntarily participate in this study, and signed inform