This Phase II trial assesses Vorolanib and Sintilimab for advanced renal cell carcinoma after previous therapy failure. Participants receive the treatment until disease progression, intolerable side effects, death, or withdrawal. The primary endpoint is progression-free survival (PFS).
Age ≥18 years and ≤75 years, any gender.
Histologically confirmed diagnosis of renal cell carcinoma.
Diagnosis of metastatic renal cell carcinoma or TNM stage IV (according to the 2017 TNM staging system). Evidence of distant metastasis by imaging or pathology.
Prior immune checkpoint inhibitors based combination therapy, dual immune combination, or immune monotherapy with disease progression, or who have received second/third line targeted monotherapy, immune monotherapy, or a change in immune-based combination therapy after failure of one of the above therapies for no more than 1 month and have completed the washout period. ECOG performance status ≤2.
Pathologically diagnosed with non-renal cell carcinoma, collecting duct carcinoma.
First-line treatment with targeted monotherapy, or progression after first-line immune checkpoint inhibitors based combination therapy, followed by more than 1 month of treatment with targeted therapies, anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies specifically targeting T cell co-stimulation or checkpoint pathways and/or incomplete washout period.
Active brain metastases.
Personal history of other malignant tumors within 3 years with a different primary site or histology than that being evaluated in this study, excluding patients with well-controlled basal cell carcinoma, squamous cell carcinoma, or cervical intraepithelial neoplasia.
Single group
Vorolanib Tablets
DrugMulti-targeted receptor tyrosine kinase inhibitor with potent inhibition of VEGFR2, KIT, PDGFR, FLT3 and RET, exerting anti-tumor effects mainly through inhibition of neovascularization.
Sintilimab Injection
DrugRecombinant human-derived immunoglobulin G (IgG4)-type anti-programmed cell death receptor-1 (PD-1) monoclonal antibody, by binding to PD-1 and blocking PD-1 binding to PD-L1 and PD-L2, disarms the immunosuppressive effect, activates T-cell function, and enhances T-cell immunosurveillance and killing ability against tumors to generate tumor immune response.
Progression-Free Survival (PFS)
Progression-free survival is assessed by investigators based on RECIST1.1, including disease progression or death from any cause.
Objective Response Rate (ORR)
Objective response rate is the proportion of participates with complete response (CR) or partial response (PR), based on RECIST1.1.
Overall Survival (OS)
Overall survival is the time from starting treatment to still being alive.
Adverse Events (AEs)
Adverse events are the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0, including type and severity.
Disease Control Rate (DCR)
Disease control rate is the proportion of participates with complete response (CR), partial response (PR) or stable disease (SD), based on RECIST1.1.
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Hao Zeng
Lead sponsor
West China Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
