The safety and efficacy of transarterial chemoembolization (TACE) + lenvatinib + programmed cell death protein 1 (PD-1) antibody of advanced unresectable hepatocellular carcinoma

• Published in: Journal of clinical oncology Vol. 40; no. 4_suppl; p. 453
• Main Authors: Zhang, Xiaoyun, Zhu, Xinrui, Liu, Chang, Lu, Wusheng, Li, Qiu, Chen, Weixia, Li, Zhiping, Lu, Qiang, Peng, Wei, Li, Chuan, Yan, Lvnan, Yang, Jiayin, Wen, Tianfu
• Format: Journal Article
• Language: English; Japanese
• Published: American Society of Clinical Oncology 01.02.2022
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2022.40.4_suppl.453

453Background: More than 70% of hepatocellular carcinoma (HCC) patients are in the intermediate or advanced stages at the time of diagnosis. TACE, TKI and PD-1 antibody are all recommended for patients with unresectable HCC (uHCC) according to Chinese HCC guidelines. There are few scientific trials to back up the safety and effecacy of TACE+TKI+PD-1 antibody for the treatment of uHCC and conversion resection. In this study, we explored the safety and efficacy of the TACE+TKI+PD-1 antibody in uHCC. Methods: This is a prospective, multicenter, cohort study (NCT04997850). Key Eligibility Criteria:18 years old ≤ age ≤ 70 years old; HCC confirmed by histopathology or cytology; No systemic treatment history. ECOG PS score 0-1; Child-Pugh A/B; BCLC stage B/C.Experience group: TACE + Lenvatinib (12mg when≥ 60kg/8mg when < 60kg QD) + Camrelizumab/ Sintilimab (200 mg ivgtt Q3W);Control group: TACE. Results: From Sep 2020 to May 2021, 38 patients were enrolled in experimental group (Table). At the cutoff date (Sep 10 2021), the median follow-up was of 33.34 weeks (Table). The conversion resection rate was 50% (19/38), and the conversion success rate was 52.6% (20/38). Among the 19 patients, 5 cases achieved complete pathological response and 1 case achieved major pathological response. The 48 weeks' OS rate and PFS were 96.4% (95%CI 92.9% to 99.9%) and 91.7%(95%CI 85.8% to 97.4%).22 patients had level 3 treatment related adverse events (TRAE), there were no level 4 and 5 TRAEs. At the last follow-up, the ORR rate based on mRECIST was 84.2%, and the DCR rate was 94.7% (Table). Conclusions: TACE + Lenvatinib + PD-1 antibody is safe and effective, and conversion resection after the triple-treatment is feasible for uHCC. Clinical trial information: 04997850.Baseline characteristics, adverse events and clinical outcomes (N=38)Baseline CharacteristicsGender, male, n (%)35(92.1%)Bodyweight, kg, median, (range)62(45-90)Etiology, [HBV/HCV/Non-HBV/HCV, n (%)]29(76.3%)/1(2.6%)/8(21.1%)ECOG PS, [0/1, n (%)]36(94.7%)/2(5.3%)AFP level, ng/ml, median(range)353(0.91-470518)DCPlevel,mAU/mL,median(range)6274(32-75000)BCLC stage, [B/C, n (%)]9(23.7%)/29(76.3%)Tumor numbers, [1/2/3, n (%)]19(50%)/15(39.5%)/4(10.5%)Treatment Related Adverse Events (TRAE), n (%)Any Adverse Events100(100%)Most common TRAEs(≥50% of patients) Abdominal pain27(71.1%) Aspartate aminotransferase increased25(65.8%) Alanine aminotransferase increased25(65.8%) Hypertension22(57.9%)≥Grade 3 TRAEs22(57.9%)RAE leading to drug reduction3(7.9%)TRAE leading to drug conclusions0(0%)Clinical OutcomesmRECISTORR32(84.2%) CR/PR/SD/PD6(15.8%)/26(68.4%)/4(10.5%)/2(5.3%)