Transcatheter arterial chemoembolization combined with arterial infusion of TQB2450 and anlotinib for stage Ⅲ hepatocellular carcinoma
Objective To investigate the efficacy and safety of transcatheter arterial chemoembolization(TACE)combined with arterial infusion of TQB2450 and anlotinib in the treatment of China liver cancer staging(CNLC)stage Ⅲhepatocellular carcinoma(HCC).Methods Twenty-eight patients with CNLC stage Ⅲ HCC received TACE in Henan Cancer Hospital from March 2022 to September 2023.During TACE treatment,TQB2450 was infused through the catheter into the hepatic artery at a dosage of 120 mg once,for 21 d as a treatment cycle.Anlotinib was orally administered at a dose of 12 mg once a day on day 3 after TACE,for consecutive 14 d,followed by a cessation period of 7 d,and the treatment cycle was also 21 d.TACE combined with arterial infusion of TQB2450 was performed for 6 cycles and was terminated till disease progression.Anlotinib treatment was terminated when disease progression occurred.The follow-up data were censored in March 2024.Enhanced MRI and CT scan were conducted every 6 weeks to assess the clinical efficacy.The objective response rate(ORR)and disease control rate(DCR)were calculated based on the mRECIST criteria,and the overall survival rate,progression-free survival and overall survival were recorded at intervals of 6,12,and 18 months after treatment.The serum levels of vascular endothelial growth factor and alpha-fetoprotein were measured before and after 6-month treatment.The occurrence of adverse reactions following treatment was documented.Results Among these 28 patients with stage Ⅲ HCC,15 were classified as stage Ⅲ a and 13 as stage Ⅲ b;18 patients presented with portal vein tumor thrombus,while lung metastasis and lymph node metastasis were observed in 7 and 6 patients respectively;liver function assessment using Child-Pugh classification revealed that 25 patients had Child-Pugh A status and only 3 had Child-Pugh B status;the EOCG PS score indicated that 27 patients had a score of 0,except for one patient who scored 1;in terms of intrahepatic tumors,there were≤3lesions in 23 patients and＞3 lesions in the remaining 5 individuals;the tumor diameter was within the range of 39 to 174(94.28±37.52)mm,while 7 patients exhibited a tumor diameter ≤50 mm and 21 displayed a tumor diameter＞50 mm.The follow-up of 28 patients ranged from 6 to 24 months,with a median follow-up time of 14.4 months.The median overall survival and progression-free survival were 11.3 and 8.9 months,respectively.The 6-month ORR was 75.0％,the DCR was 82.1％,and the overall survival rate was 85.7％.The 12-month ORR was 46.4％,the DCR was 53.6％,and the overall survival rate was 53.6％.The 18-month ORR was 28.6％,the DCR was 32.1％,and the overall survival rate was 35.7％.The 12-month ORR of 18 patients with portal vein tumor thrombus was 55.6％,and the DCR was 83.3％.The vascular endothelial growth factor and alpha-fetoprotein were significantly lower after 6-month treatment[(155.18±27.33)ng/L,(343.10±43.12)μg/L]than those before treatment[(240.30±26.45)ng/L,(945.23±45.57)μg/L](t=3.152,P＜0.001;t=4.525,P＜0.001).The adverse reactions of 28 patients included poor appetite in 14,hypertension in 10,increased transaminase(grade 1-2)in 7,thrombocytopenia in 6,leukopenia in 5,anemia in 5,hand-foot syndrome in 4,hypothyroidism in 3,and proteinuria in 1.There were no treatment terminations or deaths related to severe adverse events.Conclusion The combination of TACE with arterial infusion of TQB2450 and anlotinib is effective in the treatment of stage Ⅲ HCC,with controllable adverse reactions and high safety.
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