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
This trial does not accept healthy volunteersQualifiers
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 population
Renal cell carcinoma
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
PFS2
defined as the time from the initiation of first-line treatment to disease progression on second-line therapy or death from any cause in a real-world setting
Secondary outcomes
1L-rwPFS
Evaluate the real-world progression-free survival of first-line therapy (1L-rwPFS) for both cohorts
2L-rwPFS
Evaluate the real-world progression-free survival of second-line therapy (2L-rwPFS) for both cohorts
OS
the overall survival
ORR
Assess the objective response rate (ORR) of primary and metastatic lesions based on RECIST 1.1 criteria for both cohorts
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: