Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT05440357
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 inability to complete follow-up.
* Patients who are not appropriate to enroll due to the investigator's consideration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05440357
Study Brief:
Protocol Section:
NCT05440357