立体定向放射治疗与卡瑞利珠单抗联合治疗不可切除的肝细

StephenW

立体定向放射治疗与卡瑞利珠单抗联合治疗不可切除的肝细胞癌：一项单臂试验

    李建旭, 苏廷诗, 龚文峰, 钟建红, 闫刘英, 张洁, 李立清, 何美玲, 张瑞军, 杜友勤, 晓-王廷、梁世雄和向邦德

Hepatology International 第 16 卷，第 1179–1187 页（2022 年）引用这篇文章

    633 次访问

    2 高度计

    指标详情

抽象的
目的

立体定向放射治疗 (SBRT) 可能具有显着的免疫调节作用，可增强肿瘤对免疫检查点抑制剂的反应。该 2 期临床试验旨在评估姑息性 SBRT 与卡瑞利珠单抗（一种抗 PD1 单克隆抗体）联合治疗不可切除的肝细胞癌（uHCC）患者的安全性和有效性。
方法

在 2020 年 4 月至 2022 年 8 月期间招募了具有 uHCC、Child-Pugh A/B 肝功能和至少一个可测量病变的患者。从姑息性 SBRT 的第一天开始，每 3 周给患者静脉注射 200 mg camrelizumab。姑息性 SBRT 每周进行 5 次，剂量范围为 30-50 Gy。主要终点是客观反应率（ORR）和安全性。该试验已在 ClinicalTrials.gov (NCT04193696) 注册。
结果

招募了 21 名患者；中位辐射剂量为 40 Gy，camrelizumab 的中位周期数为 5。 ORR 为 52.4%。中位随访 19.7 个月后，中位无进展生存期和总生存期分别为 5.8 个月和 14.2 个月。 6 个月时的总生存概率为 85.7%，9 个月时为 76.2%，12 个月时为 59.9%。所有 3 级治疗相关不良事件 (TRAE) 均发生在 5 名患者 (23.8%) 中并且是可控的。未观察到 4/5 级 TRAE。
结论

姑息性 SBRT 加 camrelizumab 对 uHCC 显示出有希望的抗肿瘤活性。毒性是可控的，没有意外的安全问题。该研究为治疗 uHCC 的新治疗方法提供了证据。

StephenW

Combining stereotactic body radiotherapy with camrelizumab for unresectable hepatocellular carcinoma: a single-arm trial

    Jian-Xu Li, Ting-Shi Su, Wen-Feng Gong, Jian-Hong Zhong, Liu-Ying Yan, Jie Zhang, Li-Qing Li, Mei-Ling He, Rui-Jun Zhang, You-Qin Du, Xiao-Ting Wang, Shi-Xiong Liang & Bang-De Xiang

Hepatology International volume 16, pages 1179–1187 (2022)Cite this article

    633 Accesses

    2 Altmetric

    Metrics details

Abstract
Purpose

Stereotactic body radiotherapy (SBRT) may have significant immunomodulatory effects that enhance tumor response to immune checkpoint inhibitors. This phase 2 clinical trial was conducted to evaluate the safety and efficacy of combining palliative SBRT with camrelizumab (an anti-PD1 monoclonal antibody) in patients with unresectable hepatocellular carcinoma (uHCC).
Methods

Patients with uHCC, Child–Pugh A/B liver function, and at least one measurable lesion were enrolled between April 2020 and August 2022. Patients were administered 200 mg camrelizumab intravenously from the first day of palliative SBRT and then every 3 weeks. Palliative SBRT was delivered daily over five fractions per week, with a dose range of 30–50 Gy. The primary endpoints were objective response rate (ORR) and safety. This trial was registered at ClinicalTrials.gov (NCT04193696).
Results

Twenty-one patients were enrolled; the median radiation dose was 40 Gy, and the median number of cycles of camrelizumab was five. The ORR was 52.4%. After a median follow-up of 19.7 months, the median progression-free and overall survival were 5.8 and 14.2 months, respectively. The overall survival probability was 85.7% at 6 months, 76.2% at 9 months, and 59.9% at 12 months. All grade 3 treatment-related adverse events (TRAEs) occurred in five patients (23.8%) and were manageable. No grade 4/5 TRAEs were observed.
Conclusion

Palliative SBRT plus camrelizumab showed promising antitumor activity against uHCC. Toxicities were manageable with no unexpected safety issues. This study provides evidence of a new therapeutic method for the treatment of uHCC.

StephenW

https://link.springer.com/conten ... 072-022-10396-7.pdf