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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT03577132
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years of age
* Histologically confirmed muscle-invasive urothelial carcinoma
* Patients undergoing radical cystectomy
* Advanced status requiring neoadjuvant systemic therapy
* ECOG performance status score of 0 or 1
* Adequate organ and hematologic functions
* Available IHC data for the BASQ classification
Exclusion Criteria:
* Non-urothelial carcinoma histology
* Active autoimmune disease or inflammatory bowel disease
* Prior severe or persistent immune-related adverse events
* Previous exposure to anti-PD-1 or anti-PD-L1 therapy
* Requirement for 10 mg/d of prednisone or equivalent
* Inadequate liver, kidney function and hematologic dysfunction
* Inoperable case, such as untreated CNS metastases
* No available archival tumor tissue for evaluating the BASQ classification
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03577132
Study Brief:
Protocol Section:
NCT03577132