Observational Study
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World J Gastroenterol. Aug 28, 2014; 20(32): 11384-11393
Published online Aug 28, 2014. doi: 10.3748/wjg.v20.i32.11384
Adjuvant heparanase inhibitor PI-88 therapy for hepatocellular carcinoma recurrence
Chun-Jen Liu, Juliana Chang, Po-Huang Lee, Deng-Yn Lin, Cheng-Chung Wu, Long-Bin Jeng, Yih-Jyh Lin, King-Tong Mok, Wei-Chen Lee, Hong-Zen Yeh, Ming-Chih Ho, Sheng-Shun Yang, Mei-Due Yang, Ming-Chin Yu, Rey-Heng Hu, Cheng-Yuan Peng, Kuan-Lang Lai, Stanley Shi-Chung Chang, Pei-Jer Chen
Chun-Jen Liu, Juliana Chang, Po-Huang Lee, Ming-Chih Ho, Rey-Heng Hu, Pei-Jer Chen, Graduate Institute of Clinical Medicine, Hepatitis Research Center and Department of Internal Medicine, National Taiwan University College of Medicine and National Taiwan University Hospital, Taipei 10002, Taiwan
Deng-Yn Lin, Wei-Chen Lee, Ming-Chin Yu, Chang Gung Memorial Hospital-Linkou Medical Center and Chang Gung University, Taoyuan County 333, Taiwan
Cheng-Chung Wu, Hong-Zen Yeh, Sheng-Shun Yang, Taichung Veterans General Hospital, Taichung 40705, Taiwan
Long-Bin Jeng, Mei-Due Yang, Cheng-Yuan Peng, China Medical University Hospital, Taichung 40402, Taiwan
Yih-Jyh Lin, National Cheng Kung University Hospital, Tainan 704, Taiwan
King-Tong Mok, Kaohsiung Veterans General Hospital, Kaohsiung 81362, Taiwan
Kuan-Lang Lai, Stanley Shi-Chung Chang, Medigen Biotechnology Corporation, Taipei 11560, Taiwan
Author contributions: Chen PJ, Lai KL, Chang SSC contributed to the study design; Liu CJ, Lee PH, Lin DY, Wu CC, Jeng LB, Lin YJ, Mok KT, Lee WC, Yeh HZ, Ho MC, Yang SS, Yang MD, Yu MC, Hu RH, Peng CY contributed to the collection of patients and clinical information; Lai KL, Liu CJ contributed to the statistics; Liu CJ, Chang J, Chang SC, Chen PJ contributed to the manuscript preparation; Chen PJ Critical contributed to the review and approval.
Supported by NIH Clinical Trial Registration, No. NCT00247728 (this trial was cosponsored by Progen Industries Limited, Brisbane, Australia and Medigen Biotechnology Corporation, Taipei, Taiwan) to Chen PJ, Lai KL and Chang SSC; Taiwan Liver Disease Consortium, the National Research Program for Biopharmaceuticals, and the National Science Council, Taiwan, NSC100-2325-B-002-052; NSC102-2325-B-002-079
Correspondence to: Pei-Jer Chen, MD, PhD, Distinguished Professor, Graduate Institute of Clinical Medicine, Hepatitis Research Center and Department of Internal Medicine, National Taiwan University College of Medicine and National Taiwan University Hospital, 1 Chang-Te Street, Taipei 10002, Taiwan. peijerchen@ntu.edu.tw
Telephone: +886-2-23123456 Fax: +886-2-23825962
Received: November 16, 2013
Revised: February 12, 2014
Accepted: May 12, 2014
Published online: August 28, 2014
Processing time: 285 Days and 17.6 Hours
Core Tip

Core tip: A phase II clinical trial demonstrated that heparanase inhibitor PI-88 at 160 mg/d is safe and promising in reducing hepatocellular carcinoma (HCC) recurrence for up to one year following curative resection. This observational follow-up study extended the follow-up period to 3 years. A total of 143 patients participated in the study. PI-88 at 160 mg/d delayed the onset and frequency of HCC recurrence, and provided a clinically significant survival advantage for up to 3 years after treatment. Subgroup analyses revealed that administering PI-88 at 160 mg/d conferred the most significant survival advantage for patients at high risk of recurrence.