岭南现代临床外科2024，Vol.24Issue(1)：1-6,6.DOI:10.3969/j.issn.1009-976X.2024.01.001
mFOLFOX7化疗方案联合卡瑞利珠单抗和阿帕替尼治疗CNLC Ⅲ期肝细胞癌有效性和安全性的前瞻性研究
mFOLFOX7 venous chemotherapy plus camrelizumab and apatinib for hepatocellular carcinoma in CNLC stage Ⅲ(VIC-TRIPLET):a prospective study
摘要
Abstract
Objective The combination of anti-angiogenesis and immune checkpoint blockade showed promising outcomes for advanced HCC.Hepatic artery infusion chemotherapy(HAIC)combined with apatinib and camrelizumab could augment treatment efficacy in preliminary study.But HAIC had disadvantages such as technical limitations,expensive cost and poor patient comfort.In the present study,we aimed to investigate the efficacy and safety of Venous Infusion Chemotherapy(VIC)plus camrelizumab and apatinib for CNLC stage Ⅲ HCC.Method This study is a single-arm,open,prospective clinical study planned to enroll 35 untreated patients with stage CNLC Ⅲ hepatocellular carcinoma.Eligible pts received VIC(oxaliplatin 85 mg/m2,leucovorin 200 mg/m2,5-fluorouracil bolus 400 mg/m2 on day 1,and 5-fluorouracil infusion 2400 mg/m2 for 46 hours;q3w;6 cycles),combined with apatinib(250 mg qd)and camrelizumab(200 mg q3w).The primary study endpoints were objective response rate(ORR)assessed based on the RECIST 1.1 criteria,while the secondary study endpoints included:ORR assessed based on RECIST 1.1,mRECIST criteria,and disease control rate(DCR),progression-free survival time(PFS),overall survival time(OS),surgical conversion rate,adverse reactions(AE),etc.Results Data of 26 liver cancer patients who met the entry criteria and signed the consent form from April 2021 to April 2023 were collected and analyzed.The median follow-up was 13 months,ORR 61.5％(RECISTv1.1)and 73.1％(mRECIST),cCR rate 26.9％,pCR 23.1％,DCR 96.2％,and mPFS and mOS were not reached,both over 9 months.The surgical conversion rate was 57.7％,all achieving R0 resection.The incidence of treatment-related adverse effects(TRAE)grade 3 AEs was 50％.Conclusion The triplet treatment of VIC plus camrelizumab and apatinib showed promising antitumor activity and acceptable safety for CNLC stage Ⅲ HCC,and the preliminary study effect is similar to that of FOLFOX-HAIC combined with camrelizumab and apatinib.Especially for patients with main portal vein cancer thrombus,the combined treatment scheme is worthy of clinical application.关键词
肝细胞癌/门静脉主干癌栓/全身化疗/免疫检查点抑制剂/抗血管生成靶向药物Key words
hepatocellular carcinoma/main portal vein cancer thrombus/venous infusion chemo-therapy/ICIs/AATDs分类
医药卫生引用本文复制引用
彭林辉,叶聪婷,陈亚进,陈涛,徐云修修,王捷,陈捷,李永,黄拼搏,钟国平,陈茜..mFOLFOX7化疗方案联合卡瑞利珠单抗和阿帕替尼治疗CNLC Ⅲ期肝细胞癌有效性和安全性的前瞻性研究[J].岭南现代临床外科,2024,24(1):1-6,6.基金项目
国家卫生健康委人才交流服务中心(RCLX2315049) （RCLX2315049）
广东省消化系统疾病临床医学研究中心项目(2020B1111170004) （2020B1111170004）
