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Recruiting NCT05440357

Second-line Pharmacotherapy Patterns and Outcomes of Advanced Gastrointestinal Stromal Tumor: A Real-world Study

Trial Parameters

Condition Gastrointestinal Stromal Tumors
Sponsor Xinhua Zhang, MD
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-07-01
Completion 2025-09-30

Brief Summary

This is a prospective, multicenter, observational real-world study to explore the second-line Pharmacotherapy patterns and clinical outcomes in GIST patients who progressed on or were intolerant to first-line anticancer treatment.

Eligibility Criteria

Inclusion Criteria: * Patients who are aged ≥ 18 years. * Patients who have histologically confirmed metastatic or unresectable GIST. * Patients who received imatinib at a fixed dose or 1 other TKI as prior treatment regimens. Patients who experienced intolerance to prior therapies must have objective disease progression before enrollment. * Patients must have at least a measurable lesion according to mRECIST Version 1.1. * According to the current GIST national guidelines, patients who receive second-line treatments, including but not limited to sunitinib, imatinib dose escalation, ripretinib, dasatinib, and other drug treatments. * Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at screening. Exclusion Criteria: * Patients who previously received two or more TKIs as prior treatment regimens. * Patients with a life expectancy of fewer than three months. * Patients who are pregnant and lactating. * Patients with an estimated poor adherence or

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