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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07488533
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 75 years, inclusive.
* Histologically confirmed diagnosis of non-clear cell renal cell carcinoma (non-ccRCC), including papillary, chromophobe, collecting duct, or other non-clear cell subtypes.
* Completed radical nephrectomy (open or laparoscopic) with no evidence of residual tumor by imaging or pathology.
* High-risk features defined as one or more of the following: pT3 or higher, regional lymph node involvement (N1), sarcomatoid differentiation, tumor necrosis, Fuhrman/ISUP nuclear grade ≥3, or positive surgical margin.
* ECOG performance status of 0 or 1.
* Adequate organ function: neutrophils ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L, hemoglobin ≥9 g/dL; total bilirubin ≤1.5 × ULN; ALT/AST ≤2.5 × ULN; creatinine clearance ≥50 mL/min; INR ≤1.5.
* No prior adjuvant or neoadjuvant systemic anti-tumor therapy.
* Willing and able to provide written informed consent and comply with study procedures.
Exclusion Criteria:
* Pathological diagnosis of clear cell renal cell carcinoma or mixed histology with ≥20% clear cell component.
* Evidence of distant metastasis (M1) at baseline.
* History of active autoimmune disease (e.g., lupus, rheumatoid arthritis, inflammatory bowel disease) or current use of immunosuppressive agents.
* Uncontrolled hypertension (systolic \>150 mmHg or diastolic \>100 mmHg), significant cardiovascular disease, or uncontrolled heart failure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07488533
Study Brief:
Protocol Section:
NCT07488533