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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT07233668
Eligibility Criteria:
Inclusion Criteria:
* Participants must meet all of the following:
* Age ≥ 19 years (male or female).
* Histologically confirmed synchronous metastatic clear cell renal cell carcinoma.
* ECOG performance status 0-1.
* At least one measurable metastatic lesion (per RECIST v1.1).
* Primary renal tumor considered surgically resectable.
* IMDC intermediate- or poor-risk classification.
* Estimated life expectancy \> 3 months.
* Ability to understand and voluntarily sign informed consent.
Exclusion Criteria:
* Prior systemic therapy for metastatic RCC.
* History of another malignancy diagnosed or treated within 2 years (except for cured non-melanoma skin cancer or in-situ cancers).
* Significant comorbid conditions making participation inappropriate, such as:
Moderate to severe cardiovascular, cerebrovascular, pulmonary, or hepatic disease.
* History or suspicion of autoimmune disease incompatible with immune checkpoint inhibitor therapy.
* Requirement for systemic corticosteroid therapy \>10 mg/day prednisone equivalent, or other immunosuppressive drugs.
* Any other condition judged by the investigator to make the patient unsuitable for trial participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT07233668
Study Brief:
Protocol Section:
NCT07233668