A randomized controlled trial of Licartin for preventing hepatoma recurrence after liver transplantation.
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 ([131I] 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.


CONCLUSIONS
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.
Xu
Jing
J
Cell Engineering Research Centre, Department of Cell Biology, State Key Laboratory of Cancer Biology, Fourth Military Medical University, Xi'an, China.
Shen
Zhong-Yang
ZY
Chen
Xin-Guo
XG
Zhang
Qing
Q
Bian
Hui-Jie
HJ
Zhu
Ping
P
Xu
Hui-Yun
HY
Song
Fei
F
Yang
Xiang-Min
XM
Mi
Li
L
Zhao
Qing-Chuan
QC
Tian
Rong
R
Feng
Qiang
Q
Zhang
Si-He
SH
Li
Yu
Y
Jiang
Jian-Li
JL
Li
Ling
L
Yu
Xiao-Ling
XL
Zhang
Zheng
Z
Chen
Zhi-Nan
ZN
D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D051926:Basigin / Q000276:immunology; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000601:surgery; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000601:surgery; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D016037:Single-Blind Method; D015996:Survival Rate; D016896:Treatment Outcome; D000509:alpha-Fetoproteins / Q000378:metabolism
D000911:Antibodies, Monoclonal; C497886:BSG protein, human; D000509:alpha-Fetoproteins; C511207:metuximab; D051926:Basigin