Study of Tyroserleutide for Injection in Hepatocellular Carcinoma (HCC) Patients

Summary

This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial. Patients with no tumor lesions one month after resection of hepatocellular carcinoma will be randomized in a 1:1 ratio to 1 of the 2 treatment groups：6mg/d Tyroserleutide (injection), or placebo.

The objective is to evaluate the effect of Injectable Tyroserleutide on the recurrence-free survival,overall survival,quality of life,and the safety and tolerability of subjects after the resection of hepatocellular carcinoma

Conditions

• Hepatocellular,Carcinoma

Interventions

DRUG

Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil )

mitomycin(10mg)+Fluorouracil(1.0g),through the chemoradiative pump,every cycle,5-30 minites; Tyroserleutide for injection(30mg) ,through the micro infusion pump,every cycle,3-5 days

DRUG

the placebo ,chemotherapy(mitomycin, and Fluorouracil )

mitomycin(10mg)+Fluorouracil(1.0g),through the chemoradiative pump,every cycle,5-30 minites; the placebo(30mg) ,through the micro infusion pump,every cycle,3-5 days

Sponsors & Collaborators

• Fudan University

  collaborator OTHER

• Medpace, Inc.

  collaborator INDUSTRY

• Shenzhen Kangzhe Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Tang ZhaoYou, Academician · Shanghai Zhongshan Hospital

• Wu Meng Chao, Academician · Second Milliary Medical University,Eastern Hepatobiliary Surgery Hosipital

• Fan Jia, professor · Shanghai Zhongshan Hospital

• Yang Jia Mei, professor · Second Milliary Medical University,Eastern Hepatobiliary Surgery Hosipital

• Sun Hui Chuan, professor · Shanghai Zhongshan Hospital

• Yan Yi Qun, professor · Second Milliary Medical University,Eastern Hepatobiliary Surgery Hosipital

• Zheng Shu Sen, Academician · The First Affiliated Hospital of College of Medicine, Zhejiang Universtiy

• Wu Yu Lian, professor · Second Affiliated Hospital Zhejiang University School of Medicine

• Dong Jia Hong, professor · Chinese PLA General Hospital

• Sang Xin Ting, professor · Peking Union Medical College Hospital

• Chen Min Shan, professor · Sun Yat-sen University

• Guo Rong Ping, professor · Sun Yat-sen University

• Zheng Qi Chang, professor · Tongji Medical College,Huazhong University of Science and Technology Wuhan Union Hospital

• Xia Xiao Qin, professor · Hubei Cancer Hospital

• Liu Jing Feng, professor · First Affiliated Hospital of Fujian Medical University

• Chen Yan Ling, professor · Fujian Medical University Union Hospital

• Ying Min Gang, professor · Fujian Cancer Hospital

• Shi Xue Tao, professor · Shandong Cancer Hospital and Institute

• Liu Jun, professor · Shandong Provincial Hospital

• Liu Ji Yong, professor · Shandong Provincial Hospital

• Wu Jin Shu, professor · Hunan Provincial People's Hospital

• Wang Zhi Ming, professor · Xiangya Hospital of Central South University

• Yang Xun, professor · Sichuan Provincial People's Hospital

• Yan Lv Nan, professor · West China Hospital,Sichuan Universtiy

• Bie Ping, professor · Southwest Hospital, China

• Ma Kuan Sheng, professor · Southwest Hospital, China

• Liu Qing Guang, professor · First Affiliated Hospital Xi'an Jiaotong University

• Han Ying, professor · Xijing Hospital

• Wang Xue Hao, professor · The First Affiliated Hospital with Nanjing Medical University

• Ding Yi Tao, professor · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

• Hao Xi Shan, Academician · Tianjin Medical University Cancer Institute and Hospital

• Liu Lian Xin, professor · Center of First Affiliated Hospital of Harbin Medical University

• Li Wei, professor · The First Affiliated Hospital of Jilin University

• Wang Guang Yi, professor · The First Affiliated Hospital of Jilin University

• Jiang Bo, professor · Hunan Provincial People's Hospital

• Du Qin, professor · Second Affiliated Hospital Zhejiang University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-07-31

Primary Completion

2013-03-31

Completion

2013-08-31

Countries

• China

Study Locations