Liver Cancer Research Center for Prevention and Therapy, Tianjin Cancer Hospital Airport Hospital, Tianjin Medical University Cancer Institute and Hospital, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center for Cancer, Tianjin, China.
Neoplasma. 2023 Dec;70(6):811-818. doi: 10.4149/neo_2023_230806N413.
We assessed the efficacy and safety of sintilimab [an anti-programmed death (PD-1)] plus bevacizumab biosimilar (IBI305), and hepatic arterial infusion chemotherapy (HAIC) in patients with unresectable hepatocellular carcinoma (HCC). The patients received sintilimab (200 mg) plus IBI305 (7.5 mg/kg) and HAIC (FOLFOX for 23 h) and were treated every 3 weeks. The primary endpoint was the objective response rate (ORR) assessed by an independent review committee (IRC) per mRECIST v1.1. Twenty-nine patients were enrolled in our clinical trial (1 patient voluntarily withdrew due to adverse events after the initial treatment). Objective response was reached in 17/29 (58.6%) patients per mRECIST. A total of 19/29 (65.5%) patients became eligible for further treatment; 14 of them completed surgical resection; 1 (5.3%) achieved pathological complete response (pCR); and 5 (26.3%) reached major partial response (mPR). The 1-year OS rate was better in the PR or pCR+mPR+PR group than in the PD+SD group by either mRECIST or pathological assessment (p=0.039 and 0.006). The 1-year EFS rate was better in the PR group than in the PD+SD group by pathological assessment (p=0.007). The most common treatment-related adverse events (TEAEs) in 30 HCC patients included thrombocytopenia (40.0%), hypertension (23.3%), and leukopenia (23.3%). The grade 3-5 TEAEs that were observed were hypertension (10%), diarrhea (6.7%), asthenia (3.3%), and ascites (3.3%). Sintilimab plus IBI305 and HAIC showed promising efficacy and manageable safety in patients with unresectable HCC. It might represent a novel treatment option for these patients.
我们评估了信迪利单抗（一种抗程序性死亡（PD-1）药物）联合贝伐珠单抗生物类似药（IBI305）和肝动脉灌注化疗（HAIC）在不可切除肝细胞癌（HCC）患者中的疗效和安全性。患者接受信迪利单抗（200mg）联合 IBI305（7.5mg/kg）和 HAIC（FOLFOX 持续 23 小时），每 3 周治疗一次。主要终点是根据 mRECIST v1.1 评估的独立审查委员会（IRC）的客观缓解率（ORR）。29 例患者入组本临床试验（1 例患者因初始治疗后不良事件而自愿退出）。根据 mRECIST，17/29（58.6%）例患者达到客观缓解。共有 19/29（65.5%）例患者有资格进一步治疗；其中 14 例完成手术切除；1 例（5.3%）达到病理完全缓解（pCR）；5 例（26.3%）达到主要部分缓解（mPR）。无论根据 mRECIST 还是病理评估，PR 或 pCR+mPR+PR 组的 1 年 OS 率均优于 PD+SD 组（p=0.039 和 0.006）。PR 组的 1 年 EFS 率优于 PD+SD 组（p=0.007）。30 例 HCC 患者中最常见的治疗相关不良事件（TRAEs）包括血小板减少症（40.0%）、高血压（23.3%）和白细胞减少症（23.3%）。观察到的 3-5 级 TRAE 为高血压（10%）、腹泻（6.7%）、乏力（3.3%）和腹水（3.3%）。信迪利单抗联合 IBI305 和 HAIC 显示出在不可切除 HCC 患者中具有良好的疗效和可管理的安全性。它可能成为这些患者的一种新的治疗选择。
