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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT05245968
Eligibility Criteria:
Inclusion Criteria:
* Provided written informed consent
* Histologically confirmed GIST
* Has radiographic progression based on RECIST 1.1 during or within 6 months of the last imatinib administration at enrollment. If surgery/radiotherapy has been performed, radiographic progression based on RECIST 1.1 with imatinib must have been observed after the last surgery /radiotherapy
* Has at least one measurable lesion based on the RECIST version 1.1, except lymph nodes (not dependent on size), which should be chosen as nontarget lesions;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Exclusion Criteria:
* Corrected visual acuity \< 0.5 (using the International Visual Acuity Measurement Standard) for both eyes
* Received treatment with any other line of therapy besides imatinib for advanced GIST
* History of total gastrectomy and/or whole resection of the small intestine
* A serious illness or medical condition
* Previous or concurrent cancer that is distinct in primary disease or histology from cancer that is being evaluated in this study. However, any previous cancer curatively treated \> 5 years before the enrollment can be eligible
* Pregnancy or lactation (including lactation interruption)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05245968
Study Brief:
Protocol Section:
NCT05245968