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).
This is a Phase II, multicenter, single-arm clinical trial designed to assess the efficacy and safety of Vorolanib in combination with Sintilimab in treating advanced renal cell carcinoma following the failure of prior immune checkpoint inhibitors based combination therapy. Participants will continue to receive Vorolanib and Sintilimab until disease progression, development of unacceptable toxic effects, death, or if the physician or patient decides to withdraw from the study. The primary endpoint is progression-free survival (PFS) according to RECIST v1.1 criteria as evaluated by the investigators.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Multi-targeted receptor tyrosine kinase inhibitor with potent inhibition of VEGFR2, KIT, PDGFR, FLT3 and RET, exerting anti-tumor effects mainly through inhibition of neovascularization.
Recombinant 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.
West China Hospital
Chengdu, Sichuan, China
Progression-Free Survival (PFS)
Progression-free survival is assessed by investigators based on RECIST1.1, including disease progression or death from any cause.
Time frame: 3 years
Objective Response Rate (ORR)
Objective response rate is the proportion of participates with complete response (CR) or partial response (PR), based on RECIST1.1.
Time frame: 3 years
Overall Survival (OS)
Overall survival is the time from starting treatment to still being alive.
Time frame: 3 years
Adverse Events (AEs)
Adverse events are the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0, including type and severity.
Time frame: 3 years
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.
Time frame: 3 years
Duration of Response (DoR)
Duration of response is the time from first response (complete or partial response) to disease progression or death.
Time frame: 3 years
Quality of Life (QoL) assessed by FKSI-19
Quality of life is assessed by FKSI-19
Time frame: 3 years
Quality of Life (QoL) assessed by EQ-5D-5L
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Quality of life is assessed by EQ-5D-5L.
Time frame: 3 years
Pain Score
Evaluate pain using visual analogue scale (VAS), range from 0 to 10, higher scores predict a poor prognosis.
Time frame: 3 years