984P Sorafenib plus hepatic arterial infusion chemotherapy versus sorafenib alone for advanced hepatocellular carcinoma with major portal vein tumor thrombosis (Vp3/4): A randomized phase II trial

Abstract

Background: Combination of checkpoint inhibitors (CPIs) with anti-angiogenic agents are emerging as potential novel treatment options of hepatocellular carcinoma (HCC).Here we assessed the efficacy and safety of C+A in patients (pts) with advanced HCC.Methods: This phase II study was conducted at 25 study sites in China. Pts with advanced HCC, treatment-naive or failure to sorafenib or donafenib were enrolled. Pts received intravenous C 200 mg every 2 weeks plus A 250 mg qd. The primary endpoint was objective response assessed by independent central review per RECIST v1.1.Results: From Mar 2018 to Jan 2019, 70 pts in first-line setting and 120 pts in secondline setting were enrolled and received treatment of C+A. 168 (88%) of 190 pts were with HBV infection. As of Jan, 2020, median follow-up was 16.7 months and 14.0 months in the first-line and second-line treatment cohort, respectively. The objective response rate (ORR) assessed by independent central review per RECIST v1.1 was 34% and 23%; ORR assessed by independent central review per mRECIST was 46% and 25%; the 12-month overall survival (OS) rate was 75% and 68%, respectively. As of Apr 2020, the 18-month OS rate was 58% in the first-line cohort (table). Overall, 147 (77%) pts had grade 3 treatment-related AEs, with the most common being hypertension (34%), and increased g-GT (12%). Twenty-three (12%) pts discontinued the treatment of either drug due to a treatment-related AE.Conclusions: C+A provided high ORR, durable response with a manageable safety profile in advanced HCC pts. Notably, the remarkable survival benefit might suggest C+A is a promising strategy in advanced HCC pts.Clinical trial identification: NCT03463876.

Alternating Lenvatinib and Trans-Arterial Therapy Prolongs Overall Survival in Patients with Inter-Mediate Stage HepatoCellular Carcinoma: A Propensity Score Matching Study

“…In our study, 36.6% of patients received HAIC treatment along with alternating therapy with LEN. Recently, Wang X et al reported that the prognosis of patients treated SORA plus HAIC prolonged OS compared treated with SORA monotherapy for advanced HCC [ 19 ]. Moreover, Shi et al reported that HAIC is suitable for large unresectable HCC, such as high tumor burden (multinodular type, huge type, and invasive growth type) [ 20 ].…”