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

NCT01489566 | Unknown Phase 3

• 1 other identifier: TYS-CN-1.1PUMP III
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hepatocellular,Carcinoma,recurrence

Outcome Measures

Primary Outcomes (1)

• RFS(Recurrence Free Survival)

  The time from randomization to recurrence, metastasis or death due to any reason

  0-2years

Secondary Outcomes (2)

• OS （Overall Survival）

  0-2years

• QOL score

  0-2years

Study Arms (2)

Tyroserleutide for injection

ACTIVE COMPARATOR

the Tyroserleutide for injection at the dosage of 6mg/d

Drug: Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil )

the placebo

PLACEBO COMPARATOR

Drug: the placebo ,chemotherapy(mitomycin, and Fluorouracil )

Interventions

Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil ) DRUG

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

Tyroserleutide for injection

the placebo ,chemotherapy(mitomycin, and Fluorouracil ) DRUG

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

the placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent;
• Aged ≥ 18 years and ≤ 75 years old, male or female；
• Subject underwent a complete resection of hepatocellular carcinoma (confirmed by pathology);
• The tumor characteristics must meet one of the following:
• Tumor thrombosis in the portal vein branches is detected by either;
• Preoperative imaging, or;
• Intraoperative visual observation.
• Tumor thrombosis in the portal vein branches was not detected; and
• A single tumor with a maximum diameter ≥8cm confirmed by preoperative imaging, and histological evidence of micro vascular tumor thrombosis; or
• Preoperative imaging confirmed that there are 2 or more tumor lesions

You may not qualify if:

• Concomitant malignant primary tumor(s) in other systems is/are present;
• Tumor thrombosis in the main branch of portal vein or in hepatic vein is detected by preoperative imaging or observed during the surgery;
• The subject received any previous systemic anti-HCC therapy prior to the resection surgery (except the resection surgery), such as liver transplantation, intervention, ablation, radiotherapy, chemotherapy, molecular targeted therapy or other anti-HCC therapy;
• The subject took other study/investigational drugs 7 days prior to the resection surgery;
• The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases;
• The subject has history of study drug or similar drug allergy
• Baseline (post-resection) liver CT (normal CT + contrast enhanced CT) and chest CT scan show no tumor lesions;
• Child-Pugh score of class A at baseline
• Body surface area is \< 1.47 m2 or \> 1.92 m2;
• Concomitant malignant primary tumor(s) in other systems is/are present;
• The subject took other study/investigational drugs within 4 weeks prior to randomization;
• The baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present;
• The baseline examination suggests the presence of tumor metastasis;
• The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases;
• The subject has history of investigational drug or similar drug allergy;

Sponsors & Collaborators

• Shenzhen Kangzhe Pharmaceutical Co., Ltd.: lead
• Fudan University: collaborator
• Medpace, Inc.: collaborator

Study Sites (1)

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

H-Tyr-Ser-Leu-OH; Fluorouracil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tang ZhaoYou, Academician

  Shanghai Zhongshan Hospital

  STUDY CHAIR

• Wu Meng Chao, Academician

  Second Milliary Medical University,Eastern Hepatobiliary Surgery Hosipital

  STUDY CHAIR

• Fan Jia, professor

  Shanghai Zhongshan Hospital

  STUDY DIRECTOR

• Yang Jia Mei, professor

  Second Milliary Medical University,Eastern Hepatobiliary Surgery Hosipital

  STUDY DIRECTOR

• Sun Hui Chuan, professor

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

• Yan Yi Qun, professor

  Second Milliary Medical University,Eastern Hepatobiliary Surgery Hosipital

  PRINCIPAL INVESTIGATOR

• Zheng Shu Sen, Academician

  The First Affiliated Hospital of College of Medicine, Zhejiang Universtiy

  PRINCIPAL INVESTIGATOR

• Wu Yu Lian, professor

  Second Affiliated Hospital Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

• Dong Jia Hong, professor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Sang Xin Ting, professor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Chen Min Shan, professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Guo Rong Ping, professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Zheng Qi Chang, professor

  Tongji Medical College,Huazhong University of Science and Technology Wuhan Union Hospital

  PRINCIPAL INVESTIGATOR

• Xia Xiao Qin, professor

  Hubei Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Liu Jing Feng, professor

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Chen Yan Ling, professor

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

• Ying Min Gang, professor

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Shi Xue Tao, professor

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

• Liu Jun, professor

  Shandong Provincial Hospital

  PRINCIPAL INVESTIGATOR

• Liu Ji Yong, professor

  Shandong Provincial Hospital

  PRINCIPAL INVESTIGATOR

• Wu Jin Shu, professor

  Hunan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Wang Zhi Ming, professor

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Yang Xun, professor

  Sichuan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Yan Lv Nan, professor

  West China Hospital,Sichuan Universtiy

  PRINCIPAL INVESTIGATOR

• Bie Ping, professor

  Southwest Hospital, China

  PRINCIPAL INVESTIGATOR

• Ma Kuan Sheng, professor

  Southwest Hospital, China

  PRINCIPAL INVESTIGATOR

• Liu Qing Guang, professor

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Han Ying, professor

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

• Wang Xue Hao, professor

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Ding Yi Tao, professor

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

• Hao Xi Shan, Academician

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

• Liu Lian Xin, professor

  Center of First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

• Li Wei, professor

  The First Affiliated Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

• Wang Guang Yi, professor

  The First Affiliated Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

• Jiang Bo, professor

  Hunan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Du Qin, professor

  Second Affiliated Hospital Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 9, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 14, 2011

Record last verified: 2011-12

Locations

CN (1)