Discussion
toxicity, tumor, HCC
DISEASE, TUMOR
To our knowledge, the present study first reported the efficacy and safety of bi-specific antibody (PD-1/CTLA-4) cadonilimab plus lenvatinib combination therapy in first-line treatment of advanced HCC. Our findings suggested that this combination regimen had promising efficacy and durable response. The toxicity was manageable and no unexpected safety signal was identified.Cadonilimab plus lenvatinib demonstrated the encouraging efficacy in survival outcome analysis with a median PFS of 9.7 months and median OS was not reached. In comparison to prior findings, lenvatinib monotherapy demonstrated a median PFS of 7.4 months (Immunotherapy was found to be capable of providing durable and sustainable response, which resulted in substantial survival tails in the KM curves of OS. Despite the fact that the median OS was not reached in the present study, tumor response exhibited superior efficacy with an ORR of 35.6%, a median DoR of 13.6 months, and a median TTR of 1.61 months. The ORR was numerically superior to dual anti-PD-1/CTLA-4 therapy (This study reported high rates of AEs with cadonilimab and lenvatinib combination therapy; however, the toxicity profile was consistent with the known safety profile of each drug and the underlying disease (A limitation of this study was the absence of a standard therapy as the control arm. As an open-label, phase Ib/II study, we enrolled a relatively small sample size that was not powered to detect differences between subgroups regarding the primary endpoint objective response.