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:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT04260360
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent;
* Age ≥18 years;
* Localized T1a renal cell carcinoma;
* Maximum tumor volume of 25.0 mL;
* Performance Status (ECOG) 0-2;
* Life expectancy of at least 6 months;
* Adequate marrow, liver, and renal function;
* ANC ≥ 1.5 x 109/L
* Hemoglobin ≥ 9.5 grams/dL
* Platelets ≥ 75 x 109/L
* Total bilirubin ≤ 1.5x institutional ULN
* AST/ ALT ≤ 2.5x institutional ULN
* Creatinine ≤ 1.5x institutional ULN
* eGFR \< 60 mL/min/1.73m2
* Adequate method of birth control.
Exclusion Criteria:
* Renal cyst;
* Multifocal or bilateral renal mass;
* Known hypersensitivity to any of the study drug or reconstitution components;
* Pregnant or breastfeeding female;
* Administration of an investigational product in a clinical trial within 3 months prior to consent;
* Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;
* Known drug or alcohol abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04260360
Study Brief:
Protocol Section:
NCT04260360