32
Views
0
CrossRef citations to date
0
Altmetric
ORIGINAL RESEARCH

Efficacy and Safety Analysis of Transarterial Chemoembolization Plus Donafenib With or Without Immune Checkpoint Inhibitors for Unresectable Hepatocellular Carcinoma: A Prospective, Single-Arm, Single-Center, Phase II Clinical Study

, , &
Pages 1207-1219 | Received 07 May 2024, Accepted 21 Jun 2024, Published online: 26 Jun 2024

References

  • European Association for the Study of the Liver. Electronic address eee, European Association for the Study of the L. EASL clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2018;69(1):182–236. doi:10.1016/j.jhep.2018.03.019.
  • Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–249. doi:10.3322/caac.21660
  • Zhu XD, Sun HC. Emerging agents and regimens for hepatocellular carcinoma[J]. J Hematol Oncol. 2019;12(1):110. doi:10.1186/s13045-019-0794-6
  • Zhu XD, Tang ZY, Sun HC. Targeting angiogenesis for liver cancer: past, present, and future[J]. Genes Dis. 2020;7(3):328–335. doi:10.1016/j.gendis.2020.03.010
  • Chang Y, Jeong SW, Young Jang J, Jae Kim Y. Recent updates of transarterial chemoembolilzation in hepatocellular carcinoma. Int J Mol Sci. 2020;21(21):8165. PMID: 33142892; PMCID: PMC7662786. doi:10.3390/ijms21218165.
  • Han K, Kim JH. Transarterial chemoembolization in hepatocellular carcinoma treatment: Barcelona clinic Liver cancer staging system. World J Gastroenterol. 2015;21(36):10327–10335. PMID: 26420959; PMCID: PMC4579879. doi:10.3748/wjg.v21.i36.10327.
  • Miyayama S, Arai Y, Matsui O. Transarterial chemoembolization for hepatocellular carcinoma with vascular invasion. Br J Radiol. 2022;95(1138):20211316. PMID: 35143258; PMCID: PMC9815726. doi:10.1259/bjr.20211316.
  • Reig M, Forner A, Rimola J, et al. BCLC strategy for prognosis prediction and treatment recommendation: the 2022 update. J Hepatol. 2022;76(3):681–693. doi:10.1016/jjhep.2021.11.018
  • Kudo M, Finn RS, Qin S, et al. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised Phase 3 noninferiority trial[J]. Lancet. 2018;391(10126):1163–1173. doi:10.1016/S0140-6736(18)30207-1
  • Kambhampati S, Bauer KE, Bracci PM, et al. Nivolumab in patients with advanced hepatocellular carcinoma and Child-Pugh class B cirrhosis: safety and clinical outcomes in a retrospective case series[J]. Cancer. 2019;125(18):3234–3241. doi:10.1002/cncr.32206
  • Lim H, Ramjeesingh R, Liu D, et al. Optimizing survival by changing the landscape of targeted therapy for intermediate and advanced hepatocellular carcinoma: a systematic review[J]. J Natl Cancer Inst. 2020;113(2):123–136. doi:10.1093/jnci/djaa119
  • Li X, Qiu M, Wang S, Zhu H, Feng B, Zheng L. A Phase I dose-escalation, pharmacokinetics and food-effect study of oral donafenib in patients with advanced solid tumours. Cancer Chemother Pharmacol. 2020;85(3):593–604. doi:10.1007/s00280-020-04031-1
  • Bureau of Medical Administration and National Health Commission of the People’s Republic of China. Standardization for diagnosis and treatment of hepatocellular carcinoma (2022 edition). Zhonghua Gan Zang Bing Za Zhi. 2022;30(4):367–388. doi:10.3760/cma.j.cn501113-20220413-00193.
  • Finn RS, Ryoo BY, Merle P, et al. Pembrolizumab as second-line therapy in patients with advanced hepatocellular carcinoma in KEYNOTE-240: a randomized, double-blind, phase III trial. J Clin Oncol. 2020;38(3):193–202. doi:10.1200/JCO.19.01307
  • El-Khoueiry AB, Sangro B, Yau T, et al. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an openlabel, non-comparative, Phase 1/2 dose escalation and expansion trial. Lancet. 2017;389(10088):2492–2502. doi:10.1016/S0140-6736(17)31046-2
  • Finn RS, Qin S, Ikeda M, et al. Atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma. N Engl J Med. 2020;382(20):1894–1905. doi:10.1056/NEJMoa1915745
  • Meyer T, Fox R, Ma YT, et al. Sorafenib in combination with transarterial chemoembolisation in patients with unresectable hepatocellular carcinoma (TACE 2): a randomised placebocontrolled, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2017;2(8):565–575. doi:10.1016/S2468-1253(17)30156-5
  • Yau T, Kang YK, Kim TY, et al. Efficacy and safety of nivolumab plus ipilimumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib: the checkMate 040 randomized clinical trial. JAMA Oncol. 2020;6(11):e204564. doi:10.1001/jamaoncol.2020.4564
  • Kudo M, Izumi N, Kokudo N, et al. Management of hepatocellular carcinoma in Japan: consensus-based clinical practice guidelines proposed by the Japan Society of Hepatology (JSH) 2010 updated version. Dig Dis. 2011;29(3):339–364. doi:10.1159/000327577
  • Zhou J, Sun H, Wang Z, et al. Guidelines for the diagnosis and treatment of hepatocellular carcinoma (2019 edition). Liver Cancer. 2020;9(6):682–720. doi:10.1159/000509424
  • Llovet JM, Lencioni R. mRECIST for HCC: performance and novel refinements. J Hepatol. 2020;72(2):288–306. doi:10.1016/j.jhep.2019.09.026
  • Common Terminology Criteria for Adverse Events (CTCAE). Protocol development cancer therapy evaluation program (CTEP). Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference5x7.pdf. Accessed August 12, 2018.
  • Kobayashi S, Tajiri K, Murayama A, et al. Drug-eluting bead-transcatheter arterial chemoembolization for advanced hepatocellular carcinoma refractory to conventional lipiodol-based transcatheter arterial chemoembolization[J]. J Hepatocell Carcinoma. 2020;7:181–189. doi:10.2147/JHC.S273929
  • Kudo M, Ueshima K, Ikeda M, et al. Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial. Gut. 2020;69(8):1492–1501. doi:10.1136/gutjnl-2019-318934
  • Peng Z, Fan W, Zhu B, et al. Lenvatinib combined with transarterial chemoembolization as first-line treatment for advanced hepatocellular carcinoma: a Phase III, randomized clinical trial (LAUNCH). J Clin Oncol. 2023;41(1):117–127. doi:10.1200/JCO.22.00392
  • Qin S, Chan SL, Gu S, et al. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study. Lancet. 2023;402(10408):1133–1146. doi:10.1016/S0140-6736(23)00961-3
  • Zhong B-Y, Jin Z-C, Chen -J-J, Zhu HD, Zhu XL. Role of transarterial chemoembolization in the treatment of hepatocellular carcinoma. J Clin Transl Hepatol. 2023;11(2):480–489. doi:10.14218/JCTH.2022.00293
  • Keam SJ, Duggan S. Donafenib: first approval. Drugs. 2021;81(16):1915–1920. doi:10.1007/s40265-021-01603-0
  • Llovet JM, Castet F, Heikenwalder M, et al. Immunotherapies for hepatocellular carcinoma. Nat Rev Clin Oncol. 2022;19(3):151–172. doi:10.1038/s41571-021-00573-2
  • Quinten C, Maringwa J, Gotay CC, et al. Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. J Natl Cancer Inst. 2011;103(24):1851–1858. doi:10.1093/jnci/djr485
  • Vogel A, Qin S, Kudo M, et al. Lenvatinib versus sorafenib for first-line treatment of unresectable hepatocellular carcinoma: patient-reported outcomes from a randomised, open-label, non-inferiority, phase 3 trial. Lancet Gastroenterol Hepatol. 2021;6(8):649–658. doi:10.1016/S2468-1253(21)00110-2
  • Cao F, Yang Y, Si T, et al. The efficacy of TACE combined with lenvatinib plus sintilimab in unresectable hepatocellular carcinoma: a multicenter retrospective study. Front Oncol. 2021;11:783480. doi:10.3389/fonc.2021.783480
  • Yang XG, Sun YY, Li DS, Xu GH, Huang XQ. Efficacy and safety of drug-eluting beads transarterial chemoembolization combining immune checkpoint inhibitors in unresectable intrahepatic cholangiocarcinoma: a propensity score matching analysis. Front Immunol. 2022;13:940009. doi:10.3389/fimmu.2022.940009