Phase II Trial of Sorafenib Combined With Concurrent HAIC for Hepatocellular Carcinoma

Summary

To evaluate safety and efficacy of combined hepatic arterial infusion (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in patients with advanced hepatocellular carcinoma (HCC).

Timeline

Start

2015-06

Primary completion

2017-04

Completion

2017-04

Outcome

Met primary endpoint

paper The combination treatment met the pre-specified end point of a 3-month progression free survival rate exceeding 65%. PMID 29327075 ↗

Publications

• Results Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X.
• Results Ando E, Yamashita F, Tanaka M, Tanikawa K. A novel chemotherapy for advanced hepatocellular carcinoma with tumor thrombosis of the main trunk of the portal vein. Cancer. 1997 May 15;79(10):1890-6. doi: 10.1002/(sici)1097-0142(19970515)79:103.0.co;2-k.
• Results Luo J, Guo RP, Lai EC, Zhang YJ, Lau WY, Chen MS, Shi M. Transarterial chemoembolization for unresectable hepatocellular carcinoma with portal vein tumor thrombosis: a prospective comparative study. Ann Surg Oncol. 2011 Feb;18(2):413-20. doi: 10.1245/s10434-010-1321-8. Epub 2010 Sep 14.
• He MK, Zou RH, Li QJ, Zhou ZG, Shen JX, Zhang YF, Yu ZS, Xu L, Shi M. Phase II Study of Sorafenib Combined with Concurrent Hepatic Arterial Infusion of Oxaliplatin, 5-Fluorouracil and Leucovorin for Unresectable Hepatocellular Carcinoma with Major Portal Vein Thrombosis. Cardiovasc Intervent Radiol. 2018 May;41(5):734-743. doi: 10.1007/s00270-017-1874-z. Epub 2018 Jan 11.

Drugs

Indications