A Phase 2 Study of Camrelizumab for Advanced Hepatocellular Carcinoma: Two-Year Outcomes and Continued Treatment beyond First RECIST-Defined Progression

作者：Zhenggang Ren, Shukui Qin, Zhiqiang Meng, Zhendong Chen, Xiaoli Chai, Jianping Xiong, Yuxian Bai, Lin Yang, Hong Zhu, Weijia Jia Fang, Xiaoyan Lin, Xiaoming Chen, Enxiao Li, Linna Wang, Ping Yan, Jianjun Zou · 发表于：Liver Cancer · 年份：2021 · DOI：10.1159/000516470 · 被引用次数：26 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cancer Immunotherapy and Biomarkers、Cholangiocarcinoma and Gallbladder Cancer Studies

INTRODUCTION: In a multicenter, open-label, parallel-group, randomized, phase 2 study for pretreated advanced hepatocellular carcinoma (HCC), camrelizumab showed potent antitumor activity and acceptable safety profile. The aim of this report was to provide long-term data and evaluate potential benefit of treatment with camrelizumab beyond progression. METHODS: From November 15, 2016, to November 16, 2017, 217 patients received camrelizumab 3 mg/kg intravenously every 2 or 3 weeks. Treatment beyond first Response Evaluation Criteria in Solid Tumors (RECIST)-defined progression (TBP) with camrelizumab was allowed. RESULTS: At data cutoff of December 16, 2019 (>2 years after the last patient enrollment; median duration of follow-up, 13.2 months [IQR 5.7-25.8]), 14 (43.8%) of the 32 responses per blinded independent central review were ongoing. The median duration of response was not reached (range 2.5-30.5 + months). The ongoing response rates at 12, 18, and 24 months were 68.3% (95% confidence interval [CI] 47.7-82.2), 59.8% (95% CI 38.8-75.6), and 53.1% (95% CI 31.0-71.0), respectively. The median overall survival (OS) was 14.2 months (95% CI 11.5-16.3). The 18- and 24-month OS rates were 41.3% (95% CI 34.6-47.9) and 33.7% (95% CI 27.3-40.2), respectively. Of the 172 patients who experienced RECIST-defined progression per investigator, 102 received TBP, while 70 did not (non-TBP). The median OS was 16.9 months (95% CI 13.3-22.6) in the TBP group versus 9.4 months (95% CI 5.8-1...