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A randomized controlled trial of licartin for preventing hepatoma recurrence after liver transplantation
Author(s) -
Xu Jing,
Shen ZhongYang,
Chen XinGuo,
Zhang Qing,
Bian HuiJie,
Zhu Ping,
Xu HuiYun,
Song Fei,
Yang XiangMin,
Mi Li,
Zhao QingChuan,
Tian Rong,
Feng Qiang,
Zhang SiHe,
Li Yu,
Jiang JianLi,
Li Ling,
Yu XiaoLing,
Zhang Zheng,
Chen ZhiNan
Publication year - 2007
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.21465
Subject(s) - medicine , hazard ratio , liver transplantation , gastroenterology , randomized controlled trial , cirrhosis , confidence interval , placebo , hepatocellular carcinoma , population , transplantation , milan criteria , surgery , pathology , alternative medicine , environmental health
Orthotopic liver transplantation (OLT) is the only curative therapy of HCC with underlying cirrhosis, but due to HCC metastasis and recurrence, its benefit is limited to a small population who meet the strict selection criteria. We previously reported that Licartin ([ 131 I]mAb HAb18G/CD147) was safe and effective in treating HCC patients, and its antigen, HAb18G/CD147, was closely related to HCC invasion and metastasis. Here, we reported a randomized controlled trial to assess the post‐OLT antirecurrence efficacy of Licartin in advanced HCC patients. We randomized 60 post‐OLT patients with HCC, who were at tumor stage 3/4 and outside the Milan criteria before OLT, into 2 groups. Three weeks after OLT, the treatment group received 15.4 MBq/kg of Licartin, while the control group received placebo intravenously for 3 times with an interval of 28 days. At 1‐year follow‐up, the recurrence rate significantly decreased by 30.4% ( P = 0.0174) and the survival rate increased by 20.6% ( P = 0.0289) in the treatment group, compared with those in the control group. For the control group versus the treatment group, the hazard ratio for recurrence was 3.60 (95% confidence interval [CI], 1.50‐8.60) and that for death was 3.87 (95% CI, 1.23–12.21). Licartin treatment also resulted in an earlier decreased AFP level and a longer time of normal AFP level than placebo ( P = 0.0016). No Licartin‐related toxic effects were observed. Conclusion: Licartin is a promising drug for preventing post‐OLT tumor recurrence in advanced HCC patients excluded by the currently strict criteria for OLT. HAb18G/CD147 can be a good drug target. (H EPATOLOGY 2007;45:269–276.)