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 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT07165418
Eligibility Criteria:
Inclusion Criteria:
1. Pathologically confirmed renal clear cell carcinoma (histological or cytological);
2. Subjects who have failed prior treatment with a single anti-PD-1/PD-L1 agent or a combination of anti-PD-1/PD-L1 and anti-VEGFR TKI;
3. Age 18 to 80 years;
4. Estimated survival exceeding 12 weeks;
5. KPS score ≥70;
6. At least one measurable lesion per RECIST 1.1 criteria, which has not received prior radiation therapy;
7. Adequate organ function levels;
8. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization; all enrolled subjects (male or female) must use effective barrier contraception throughout treatment and for 4 weeks post-treatment;
9. Subjects must be capable of understanding and voluntarily signing the informed consent form, which must be signed prior to any trial procedures.
Exclusion Criteria:
1. Patients who have received one or more prior systemic anticancer treatment regimens for clear cell renal cell carcinoma;
2. Patients who have not previously received immunosuppressive therapy for advanced renal cell carcinoma;
3. Subjects currently undergoing anticancer therapy (excluding local radiotherapy for bone metastases);
4. Subjects with known hypersensitivity to similar drugs;
5. Subjects with active infectious diseases;
6. Any uncontrolled clinical condition;
7. Undergone major surgery within 4 weeks prior to enrollment;
8. History of significant psychiatric disorders that may impair understanding of informed consent or compliance with the study protocol;
9. Any condition affecting the subject's ability to swallow medication;
10. Pregnant or lactating women;
11. Subjects with severe pulmonary disease, asthma, or COPD history, with pulmonary function tests indicating moderate or greater impairment;
12. Any other factors deemed by the investigator to make the subject unsuitable for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07165418
Study Brief:
Protocol Section:
NCT07165418