Efficacy and safety of stereotactic body radiotherapy combined with Camrelizumab and Apatinib in hepatocellular carcinoma patients with portal vein tumor thrombus
单位:[1]Huazhong University of Science and Technology, China.[2]Huazhong University of Science and Technology, Wuhan, China.[3]Yangtze University, China.[4]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.华中科技大学同济医学院附属协和医院[5]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China.华中科技大学同济医学院附属协和医院[6]Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China.华中科技大学同济医学院附属协和医院[7]Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.华中科技大学同济医学院附属同济医院[8]Shiyan Renmin Hospital, China.[9]Renmin Hospital of Wuhan University, Wuhan, Hubei, China.[10]Zhongnan Hospital of Wuhan University, China.[11]Tongji Hospital, Wuhan, China.华中科技大学同济医学院附属同济医院[12]Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.华中科技大学同济医学院附属协和医院
This study aimed to evaluate the efficacy and safety of camrelizumab plus apatinib with or without stereotactic body radiotherapy (SBRT) as first-line therapy for hepatocellular carcinoma (HCC) patients with portal vein tumor thrombus (PVTT).This is a multicenter, open-label, non-comparative, randomized trial that recruited HCC patients with type II/III/IV PVTT, who had not previously received systemic therapy. Patients were randomly assigned (2:1) to receive camrelizumab (200 mg, Q3W) and apatinib (250 mg, QD) with or without SBRT (95% PTV, 36 - 40 Gy/6 - 8 Gy). The primary endpoint was overall survival (OS), and the secondary endpoints were progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), time to progression (TTP) and safety.Sixty patients were enrolled and randomly assigned to two prospective cohorts. Median OS were 12.7 months (95% CI, 10.2-NA) and 8.6 months (95% CI, 5.6-NA), and median PFS were 4.6 months (95% CI, 3.3-7.0) and 2.5 months (95% CI, 2.0-7.6) for the SBRT and non-SBRT cohorts, respectively. The ORR and DCR were 47.5% and 72.5% in the SBRT cohort, and 20.0% and 40.0% in the non-SBRT cohort. The most common treatment-related adverse events of any grade were hypertension (55.0%), hand-foot syndrome (51.7%), and leukopenia (50.0%). Grade ≥ 3 was reported in 13 (21.7%) patients.First-line treatment with camrelizumab-apatinib combined with or without SBRT showed clinical benefits in HCC patients with PVTT, with an acceptable safety profile. Thus, these combination regimens may be potential options for such patients.
基金:
Jun Xue received grant from National Natural Science Foundation of China (U21A20376), Yue Hu received grant from National Natural Science Foundation of China (81902934) and Min Zhou received grant from National Natural Science Foundation of China (81901714).
第一作者单位:[1]Huazhong University of Science and Technology, China.
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推荐引用方式(GB/T 7714):
Hu Yue,Zhou Min,Tang Jing,et al.Efficacy and safety of stereotactic body radiotherapy combined with Camrelizumab and Apatinib in hepatocellular carcinoma patients with portal vein tumor thrombus[J].Clinical cancer research : an official journal of the American Association for Cancer Research.2023,29(20):4088-4097.doi:10.1158/1078-0432.CCR-22-2592.
APA:
Hu Yue,Zhou Min,Tang Jing,Li Shuang,Liu Hongli...&Xue Jun.(2023).Efficacy and safety of stereotactic body radiotherapy combined with Camrelizumab and Apatinib in hepatocellular carcinoma patients with portal vein tumor thrombus.Clinical cancer research : an official journal of the American Association for Cancer Research,29,(20)
MLA:
Hu Yue,et al."Efficacy and safety of stereotactic body radiotherapy combined with Camrelizumab and Apatinib in hepatocellular carcinoma patients with portal vein tumor thrombus".Clinical cancer research : an official journal of the American Association for Cancer Research 29..20(2023):4088-4097