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 (#x3e;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 5.8–14.8) in the non-TBP group, and the 18- and 24-month OS rates were 47.5% (95% CI 37.3–56.9) versus 33.1% (95% CI 22.3–44.3) and 38.8% (95% CI 29.2–48.4) versus 23.2% (95% CI 13.8–34.1), respectively. No new safety signals of camrelizumab were observed. Conclusions: With prolonged follow-up, camrelizumab continues to demonstrate the durable response and long survival in pretreated advanced HCC patients with manageable toxicities, especially in those who continued the treatment beyond first RECIST-defined progression.
Liver Cancer

中文翻译：

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Camrelizumab 治疗晚期肝细胞癌的 2 期研究：两年结果和超出第一个 RECIST 定义的进展的继续治疗

简介：在一项针对预处理过的晚期肝细胞癌 (HCC) 的多中心、开放标签、平行组、随机 2 期研究中，camrelizumab 显示出有效的抗肿瘤活性和可接受的安全性。本报告的目的是提供长期数据并评估卡瑞利珠单抗治疗超越进展的潜在益处。方法：从 2016 年 11 月 15 日至 2017 年 11 月 16 日，217 名患者每 2 或 3 周静脉注射 3 mg/kg 卡瑞利珠单抗。允许使用卡瑞利珠单抗进行超出实体瘤第一反应评估标准 (RECIST) 定义的进展 (TBP) 的治疗。结果：在 2019 年 12 月 16 日的数据截止日期（#x3e；最后一次患者入组后 2 年；中位随访时间为 13.2 个月 [IQR 5.7-25.8]），每个盲法独立中心的 32 个响应中有 14 个（43.8%）审查正在进行中。未达到中位反应持续时间（范围 2.5-30.5 + 个月）。12、18 和 24 个月的持续反应率为 68.3%（95% 置信区间 [CI] 47.7–82.2）、59.8%（95% CI 38.8–75.6）和 53.1%（95% CI 31.0–71.0） ， 分别。中位总生存期 (OS) 为 14.2 个月 (95% CI 11.5–16.3)。18 个月和 24 个月的 OS 率分别为 41.3% (95% CI 34.6–47.9) 和 33.7% (95% CI 27.3–40.2)。在每位研究者经历了 RECIST 定义的进展的 172 名患者中，102 名接受了 TBP，而 70 名没有（非 TBP）。TBP 组的中位 OS 为 16.9 个月（95% CI 13.3-22.6），而 TBP 组为 9 个月。非 TBP 组 4 个月 (95% CI 5.8–14.8)，18 个月和 24 个月 OS 率为 47.5% (95% CI 37.3–56.9) 与 33.1% (95% CI 22.3–44.3) 和分别为 38.8% (95% CI 29.2–48.4) 和 23.2% (95% CI 13.8–34.1)。没有观察到卡瑞利珠单抗的新安全信号。结论：随着长期随访，camrelizumab 继续证明在经过治疗的晚期 HCC 患者中具有可控制的毒性的持久反应和长生存期，特别是在那些在首次 RECIST 定义的进展后继续治疗的患者中。
肝癌