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 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
NCT ID:
NCT04588168
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed primary or recurrent bladder cancer.
* Planned to undergo transurethral resection of bladder tumor (TURBT) or modified GC regimen neoadjuvant chemotherapy plus radical total cystectomy.
* 18 years old and older.
* Willing to give valid written informed consent.
* No contraindications to the MRI(magnetic resonance imaging) and MRI contrast agent.
Exclusion Criteria:
* Abnormal liver function (1.5 times higher than normal).
* Glomerular filtration rate \< 60ml /min·kg.
* Heart failure.
* Acute myocardial infarction.
* Severe heart and lung disease.
* Hypotension and hypoxia.
* Brain metastases, or other known central nervous system metastases.
* A history of severe central nervous system diseases, including unexplained loss of consciousness or transient ischemic attack.
* Known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis and other active infections, etc.
* Pregnant or lactating women.
* Patients participating in other drug trials.
* Patients with poor general condition (eg malnutrition, dehydration). Behavioral status score (ZPS quintile) ≥ 2.
* Patients with previous autoimmune diseases or existing autoimmune diseases. (including controlled or uncontrolled drugs).
* Patients undergoing organ transplantation (transplantation of liver, kidney, heart, lung and other organs) or those who require long-term administration of immunosuppressive agents due to personal conditions.
* Those who are intolerant or allergic to cytotoxic chemotherapeutic drugs.
* Bone marrow transplantation, severe leukopenia.
* Patients with severe infection or trauma.
* Any condition based on the investigation's clinical judgment that the patient is not suitable for completing this study (such as not meeting the patient's most beneficial treatment, patient compliance, etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04588168
Study Brief:
Protocol Section:
NCT04588168