Clinical Research of Drug Holiday Based on MRD Detection in GIST Patients at High Risk of Recurrence
Recruiting now
Conditions studied: Gastrointestinal Stromal Tumors
In brief
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.
Key facts
- Study ID
- NCT05867901
- Run by
- Peking University People's Hospital
- People needed
- 40
- Starts
- 2023-06-01
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2023-05-31
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 informed consent. In the follow-up study, they could provide the clinical pathological data and imaging data needed for the study process, cooperate with the follow-up and collect the blood of the clinical efficacy evaluation, and agree to use the test data for the follow-up study and product development.
You may not qualify if…
- ① Fresh or paraffin tissue of the surgical tumor is not available;
- ② Not receiving the assigned treatment or change therapy before disease progression;
- ③ Unable to cooperate with follow-up with the study according to defined clinical period;
- ④ Unable to take or provide defined imaging assessment examinations;
- ⑤ Other conditions that investigators consider inappropriate for enrollment.
Where it is running
- Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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