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

ConditionGastrointestinal Stromal Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorPeking University People's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

High-risk GIST patients who have been treated with imatinib for more than 3 years after surgery and have no gross lesions in imaging examination

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: patients cohort

Trial outcomes

Primary outcomes

1

Progress-free Survival

Progression-free survival after patients first enter the drug holiday

Time frame
From date when patients first enter the drug holiday until the date of imaging examinations confirmed disease progression up to 3 years
2

Drug re-use rate

The proportion of patients who take drug re-use due to disease progression within 3 years after first entering drug holiday

Time frame
3 years from the time when patients first enter the drug holiday
3

Drug retreatment response rate

Drug response rate among patients who take drug re-use due to disease progression within 3 years after first entering drug holiday

Time frame
3 years from the time when patients first enter the drug holiday

Secondary outcomes

1

Overall Survival

Overall survival after patients first enter the drug holiday

Time frame
From date when patients first enter the drug holiday until the date of death up to 3 years
2

genetic mutation profiling of ctDNA-MRD

Results of genetic mutations in patients after the conversion of MRD from negative to positive, especially the detection of secondary imatinib resistance mutations

Time frame
3 years from the time when patients first enter the drug holiday
3

MRD versus imaging examination

compare the time of MRD conversion and the time of disease progression assessed by imaging examination

Time frame
3 years from the time when patients first enter the drug holiday

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Source ClinicalTrials.gov
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