About this trial
TKI monotherapy or TKI/IO combination therapy is the standard first-line treatment for low- and intermediate-risk advanced renal cell carcinoma (RCC). In clinical practice, after the failure of first-line therapy, sequential treatment is often selected based on the initial regimen, with options including TKI/IO therapy or TKI therapy. In the real-world setting of low- and intermediate-risk advanced RCC in China, which sequential treatment strategy-TKI/IO-TKI or TKI-TKI/IO-provides greater survival benefits for patients? This study aims to compare the efficacy, safety, and cost-effectiveness of TKI/IO-TKI sequential therapy versus TKI-TKI/IO sequential therapy in real-world low- and intermediate-risk mRCC patients. The objective is to accurately identify the optimal patient subgroups for each treatment strategy, optimize treatment plans, improve patient quality of life, reduce healthcare costs, provide guidance and reference for the clinical management of low- and intermediate-risk mRCC patients, and contribute to the refinement and updating of related Chinese treatment guidelines.
Eligibility criteria
Qualifiers
Subjects with histologically confirmed unresectable metastatic renal cell carcinoma (mRCC) will be included in the study. Previous nephrectomy or metastasectomy is allowed, but no prior systemic anticancer therapy targeting RCC is permitted.
Classified as low- or intermediate-risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria.
Male or female subjects aged 18 years or older at the time of signing the informed consent form.
Defined as Chinese ethnicity, with both biological parents and all four biological grandparents being of Chinese descent.
Disqualifiers
Requiring intermittent oxygen supplementation at rest, or long-term oxygen therapy.
Clinically significant cardiovascular disease within 6 months prior to the first dose of study intervention.
Severe active, non-healing wound, ulcer, or fracture.
Use of colony-stimulating factors (e.g., G-CSF, GM-CSF), recombinant erythropoietin (EPO), or blood transfusion within 28 days prior to the first dose of study intervention.
Trial design
Treatments tested in this trial
- Not listed