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 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT06472895
Eligibility Criteria:
Inclusion Criteria:
* Provide written informed consent/assent for the trial.
* Be ≥18 and ≤ 75 years of age on day of signing informed consent, no matter male or female.
* IMDC favourable risk（IMDC score 0）.
* ECOG PS 0-1.
* Have estimated life expectancy of at least 3 months.
* Have histologically or cytologically confirmed diagnosis of RCC with mainly clear cell carcinoma component.
* Have received no prior systemic therapy for advanced RCC，Including but not limited to Immunotherapy, target therapy, chemotherapy, biological therapy, etc.
Note: Prior neoadjuvant/adjuvant therapies are acceptable if disease progression occurred \> 6 months after last dosage of neoadjuvant/adjuvant treatment.
* Have measurable disease per RECIST v1.1 .
* Adequate organ function.
* Contraception from entering the trial，until 120 days after the last administration of the investigational drug.
* Willing to comply with the scheduled visits, treatment plans, and other requirements of the trial.
Exclusion Criteria:
* non-clear cell renal cell carcinoma，nccRCC（e.g. chromophobe, papillary)
* Has active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Subjects with diabetes type I, vitiligo, psoriasis, hypo-or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
* Has a known additional malignancy that has progressed or has required active treatment in the last 5 years.
Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or carcinoma in situ are not excluded.
* Eligible for surgery.
* History of severe bleeding or coagulation disorders.
* History of abdominal fistula or gastrointestinal perforation related to anti VEGF therapy.
* Has previously received systemic therapy.
* Has newly diagnosed brain metastases or known symptomatic brain metastases requiring steroids.
* Had major surgery 4 weeks prior to receiving first dose of trial treatment.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to receiving first dose of trial treatment.
* Has an active tuberculosis and syphilitic infection.
* Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV antibodies).
* Has known active Hepatitis B (e.g., Hepatitis B surface antigen \[HBsAg\] reactive and HBV-DNA\>2000 IU/ml) or Hepatitis C virus (e.g., HCV RNA \[qualitative\] is detected).
* Has been pregnant or breastfeeding.
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06472895
Study Brief:
Protocol Section:
NCT06472895