TY - JOUR T1 - Effect of Huaier granule on recurrence after curative resection of HCC: a multicentre, randomised clinical trial JF - Gut JO - Gut SP - 2006 LP - 2016 DO - 10.1136/gutjnl-2018-315983 VL - 67 IS - 11 AU - Qian Chen AU - Chang Shu AU - Arian D Laurence AU - Yan Chen AU - Bao-Gang Peng AU - Zuo-Jun Zhen AU - Jian-Qiang Cai AU - Yi-Tao Ding AU - Le-Qun Li AU - Yu-Bao Zhang AU - Qi-Chang Zheng AU - Ge-Liang Xu AU - Bo Li AU - Wei-Ping Zhou AU - Shou-Wang Cai AU - Xi-Yan Wang AU - Hao Wen AU - Xin-Yu Peng AU - Xue-Wen Zhang AU - Chao-Liu Dai AU - Ping Bie AU - Bao-Cai Xing AU - Zhi-Ren Fu AU - Lian-Xin Liu AU - Yi Mu AU - Ling Zhang AU - Qi-Shun Zhang AU - Bin Jiang AU - Hai-Xin Qian AU - Yi-Jun Wang AU - Jing-Feng Liu AU - Xi-Hu Qin AU - Qiang Li AU - Ping Yin AU - Zhi-Wei Zhang AU - Xiao-Ping Chen Y1 - 2018/11/01 UR - http://gut.bmj.com/content/67/11/2006.abstract N2 - 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. ER -