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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT04479904
Eligibility Criteria:
Inclusion Criteria:
1. Voluntary participation and written informed consent;
2. Aged 18-75 years (inclusive), males and females;
3. Those with histopathologically diagnosed iCCA, who had previously undergone but failed first-line systematic chemotherapy;
4. FGFR2 fusion/rearrangement confirmed by tests conducted in designated central laboratory;
5. At least one measurable lesion that has not been treated locally;
6. ECOG score of 0-1;
7. Expected survival ≥ 12 weeks;
Exclusion Criteria:
1. Presence of multiple factors affecting oral medications;
2. Wounds unhealed over a long period of time, or fractures not completely healed;
3. Known or suspected allergy to investigational drug or any drug related to this trial.
4. Known cases of CNS(Central Nervous System) metastasis;
5. Uncontrolled cardiac diseases or symptoms;
6. Patients with congenital or acquired immunodeficiency (such as HIV positive), or a history of organ transplants;
7. Patients previously treated with FGFR inhibitors (such as erdafitinib)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04479904
Study Brief:
Protocol Section:
NCT04479904