drugset / Trial / NCT02767375
Hepatic Arterial Infusion Chemotherapy(HAIC) for Hepatoma After Resection
RandomizedParallel-groupOpen-labelPrevention
Summary
To study if the addition of HAIC following complete removal of early stage liver cancer of HCC will prevent or delay the recurrence of the disease. Half of the participant will receive two cycles of the HAIC after the hepatectomy, while the other half will return to the baseline surveillance schedule.
Timeline
- Start
- 2015-02
- Primary completion
- 2017-12
- Completion
- 2018-12
Publications
- Background Clinical Practice Guidelines for Hepatocellular Carcinoma Differ between Japan, United States, and Europe. Liver Cancer. 2015 Mar;4(2):85-95. doi: 10.1159/000367730. No abstract available.
- Background Qi X, Liu L, Wang D, Li H, Su C, Guo X. Hepatic resection alone versus in combination with pre- and post-operative transarterial chemoembolization for the treatment of hepatocellular carcinoma: A systematic review and meta-analysis. Oncotarget. 2015 Nov 3;6(34):36838-59. doi: 10.18632/oncotarget.5426.
- Background Lee JH, Lee Y, Lee M, Heo MK, Song JS, Kim KH, Lee H, Yi NJ, Lee KW, Suh KS, Bae YS, Kim YJ. A phase I/IIa study of adjuvant immunotherapy with tumour antigen-pulsed dendritic cells in patients with hepatocellular carcinoma. Br J Cancer. 2015 Dec 22;113(12):1666-76. doi: 10.1038/bjc.2015.430. Epub 2015 Dec 10.
- Background Zhong JH, Li H, Li LQ, You XM, Zhang Y, Zhao YN, Liu JY, Xiang BD, Wu GB. Adjuvant therapy options following curative treatment of hepatocellular carcinoma: a systematic review of randomized trials. Eur J Surg Oncol. 2012 Apr;38(4):286-95. doi: 10.1016/j.ejso.2012.01.006. Epub 2012 Jan 24.
- Background Kumamoto T, Tanaka K, Matsuo K, Takeda K, Nojiri K, Mori R, Taniguchi K, Matsuyama R, Ueda M, Akiyama H, Ichikawa Y, Ota M, Endo I. Adjuvant hepatic arterial infusion chemotherapy with 5-Fluorouracil and interferon after curative resection of hepatocellular carcinoma: a preliminary report. Anticancer Res. 2013 Dec;33(12):5585-90.
- Background Tung-Ping Poon R, Fan ST, Wong J. Risk factors, prevention, and management of postoperative recurrence after resection of hepatocellular carcinoma. Ann Surg. 2000 Jul;232(1):10-24. doi: 10.1097/00000658-200007000-00003.
- Background Nitta H, Beppu T, Imai K, Hayashi H, Chikamoto A, Baba H. Adjuvant hepatic arterial infusion chemotherapy after hepatic resection of hepatocellular carcinoma with macroscopic vascular invasion. World J Surg. 2013 May;37(5):1034-42. doi: 10.1007/s00268-013-1957-1.
- Background Nagano H. Treatment of advanced hepatocellular carcinoma: intraarterial infusion chemotherapy combined with interferon. Oncology. 2010 Jul;78 Suppl 1:142-7. doi: 10.1159/000315243. Epub 2010 Jul 8.
- Background Song MJ. Hepatic artery infusion chemotherapy for advanced hepatocellular carcinoma. World J Gastroenterol. 2015 Apr 7;21(13):3843-9. doi: 10.3748/wjg.v21.i13.3843.
- Background Shiozawa K, Watanabe M, Ikehara T, Kogame M, Matsui T, Okano N, Kikuchi Y, Nagai H, Ishii K, Makino H, Igarashi Y, Sumino Y. Comparison of Sorafenib and Hepatic Arterial Infusion Chemotherapy for Advanced Hepatocellular Carcinoma: A Propensity Score Matching Study. Hepatogastroenterology. 2014 Jun;61(132):885-91.
- Background Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.
- Results Korean Liver Cancer Study Group (KLCSG); National Cancer Center, Korea (NCC). 2014 Korean Liver Cancer Study Group-National Cancer Center Korea practice guideline for the management of hepatocellular carcinoma. Korean J Radiol. 2015 May-Jun;16(3):465-522. doi: 10.3348/kjr.2015.16.3.465. Epub 2015 May 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | Other |
| Comparator | fluorouracil | Small molecule | 1500 mg/m2 | Other |