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

NCT05867901 | Recruiting DMC

• 1 other identifier: 2023-076
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Stromal Tumors

Keywords

Gastrointestinal Stromal Tumors; Drug Holiday; Minimal Residual Disease; Circulating Tumor DNA

Outcome Measures

Primary Outcomes (3)

• Progress-free Survival

  Progression-free survival after patients first enter the drug holiday

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

• 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

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

• 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

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

Secondary Outcomes (3)

• Overall Survival

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

• genetic mutation profiling of ctDNA-MRD

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

• MRD versus imaging examination

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

Study Arms (1)

patients cohort

As an one-arm observational clinical trial, we have only one patients cohort.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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

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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (13)

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• Kang YK, Kim HD, Kim HJ, Park YS, Beck MY, Ryu MH. Interruption of imatinib in advanced gastrointestinal stromal tumor after prolonged imatinib maintenance in the absence of gross tumor lesions. Gastric Cancer. 2023 Jul;26(4):604-613. doi: 10.1007/s10120-023-01377-2. Epub 2023 Mar 8.

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Biospecimen

Retention: SAMPLES WITH DNA

tumor tissues and peripheral blood sample

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhidong Gao, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhidong Gao, MD

CONTACT

010-88326600; gaozhidong@pkuph.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor of Department of Gastrointestinal Surgery

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 22, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

CN (1)