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Effect of Huaier granule on recurrence after curative resection of HCC: A multicentre, randomised clinical trial

Lookup NU author(s): Dr Arian Laurence

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Abstract

© Article author(s) 2018. All rights reserved. Objective: There is little evidence that adjuvant therapy after radical surgical resection of hepatocellular carcinoma (HCC) improves recurrence-free survival (RFS) or overall survival (OS). We conducted a multicentre, randomised, controlled, phase IV trial evaluating the benefit of an aqueous extract of Trametes robinophila Murr (Huaier granule) to address this unmet need. Design and results: A total of 1044 patients were randomised in 2:1 ratio to receive either Huaier or no further treatment (controls) for a maximum of 96 weeks. The primary endpoint was RFS. Secondary endpoints included OS and tumour extrahepatic recurrence rate (ERR). The Huaier (n=686) and control groups (n=316) had a mean RFS of 75.5 weeks and 68.5 weeks, respectively (HR 0.67; 95% CI 0.55 to 0.81). The difference in the RFS rate between Huaier and control groups was 62.39% and 49.05% (95% CI 6.74 to 19.94; p=0.0001); this led to an OS rate in the Huaier and control groups of 95.19% and 91.46%, respectively (95% CI 0.26 to 7.21; p=0.0207). The tumour ERR between Huaier and control groups was 8.60% and 13.61% (95% CI -12.59 to -2.50; p=0.0018), respectively. Conclusions: This is the first nationwide multicentre study, involving 39 centres and 1044 patients, to prove the effectiveness of Huaier granule as adjuvant therapy for HCC after curative liver resection. It demonstrated a significant prolongation of RFS and reduced extrahepatic recurrence in Huaier group. Trial registration: NCT01770431; Post-results.

Publication metadata

Author(s): Chen Q, Shu C, Laurence AD, Chen Y, Peng B-G, Zhen Z-J, Cai J-Q, Ding Y-T, Li L-Q, Zhang Y-B, Zheng Q-C, Xu G-L, Li B, Zhou W-P, Cai S-W, Wang X-Y, Wen H, Peng X-Y, Zhang X-W, Dai C-L, Bie P, Xing B-C, Fu Z-R, Liu L-X, Mu Y, Zhang L, Zhang Q-S, Jiang B, Qian H-X, Wang Y-J, Liu J-F, Qin X-H, Li Q, Yin P, Zhang Z-W, Chen X-P

Publication type: Article

Publication status: Published

Journal: Gut

Year: 2018

Volume: 67

Issue: 11

Pages: 2006-2016

Print publication date: 01/11/2018

Online publication date: 25/05/2018

Acceptance date: 23/04/2018

ISSN (print): 0017-5749

ISSN (electronic): 1468-3288

Publisher: BMJ Publishing Group

URL: https://doi.org/10.1136/gutjnl-2018-315983

DOI: 10.1136/gutjnl-2018-315983

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