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 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT07261592
Eligibility Criteria:
Inclusion Criteria:
* Histopathologic confirmed unresectable advanced or metastatic bladder cancer, except for those with squamous differentiation, glandular differentiation or both;
* Failure of first-line treatment;
* There is at least one measurable lesion according to RECIST 1.1;
* Archived tumor tissue samples or tumor biopsies must be provided;
* ECOG score of 0-1 an an estimated survival of at least 6 months;
* Adequate organ function;
* Patients voluntarily participated in this study, signed the informed consent form, and had good compliance;
* Women with fertility must consent to contraception during the study and for 6 months after the last dose of study drug.
Exclusion Criteria:
* Patients who received platinum-based chemotherapy after failure of first-line treatment;
* Patients who received platinum-based chemotherapy withnin a 24 month before this trial;
* Those who have received other anti-tumor treatment or participated in other clinical studies within 4 weeks before the start of the study, or have not recovered from the last toxicity (except grade 2 hair loss and grade 1 neurotoxicity);
* Concomitant disease such as uncontrolled hypertension or diabetes, renal inadequacy, myocardial infarction, severe angina;
* Female subjects who are pregnant, breastfeeding or planning to become pregnant during the study;
* Patients with serious physical or mental illnesses.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07261592
Study Brief:
Protocol Section:
NCT07261592