Study of Drug Holiday Based on MRD Detection in High-Risk Gastrointestinal Stromal Tumor Patients Monitoring Recurrence and Treatment Outcomes After Surgery and Imatinib Therapy

What this Trial Is About

Researchers are investigating the use of minimal residual disease MRD detection through liquid biopsy to monitor postoperative recurrence and guide treatment in patients with high-risk gastrointestinal stromal tumors GIST. The study focuses on patients who have undergone surgery and long-term treatment with the drug imatinib, aiming to evaluate whether a drug holiday approach, where medication is paused based on MRD results, affects progression-free survival, overall survival, and the development of drug resistance. This observational trial also examines the response to restarting imatinib if the disease progresses after drug withdrawal. This one-arm observational clinical trial follows a single group of high-risk GIST patients who have completed at least three years of imatinib after surgery with disease control and negative baseline MRD. Participants will stop taking imatinib and be monitored using MRD detection and imaging to observe recurrence or progression. If disease progression occurs, imatinib may be restarted. The study period includes up to three years of follow-up after entering the drug holiday phase to assess survival outcomes, drug re-use rates, genetic mutation changes, and comparison of MRD with imaging results. Participants will undergo regular clinical and imaging evaluations, along with blood tests to detect circulating tumor DNA, which helps track MRD status. Researchers will measure progression-free survival from the start of drug withdrawal until disease progression, as well as overall survival up to three years. The study requires patients to cooperate with follow-up visits, provide clinical and imaging data, and allow use of their test results for ongoing research. This careful monitoring aims to understand the potential benefits and risks of pausing imatinib based on MRD findings in high-risk GIST patients.

Clinical Research of Drug Holiday Based on MRD Detection in GIST Patients at High Risk of Recurrence