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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Fudan University
Medpace, Inc.
Information provided by (Responsible Party):
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01489566
First received: December 1, 2011
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Hepatocellular,Carcinoma
Drug: Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil )
Drug: the placebo ,chemotherapy(mitomycin, and Fluorouracil )
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Phase III Clinical Trial to Evaluate the Safety and Efficacy of Injectable Tyroserleutide to Treat Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Shenzhen Kangzhe Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • RFS(Recurrence Free Survival) [ Time Frame: 0-2years ] [ Designated as safety issue: No ]
    The time from randomization to recurrence, metastasis or death due to any reason


Secondary Outcome Measures:
  • OS (Overall Survival) [ Time Frame: 0-2years ] [ Designated as safety issue: No ]
    The time from randomization to death due to any reason

  • QOL score [ Time Frame: 0-2years ] [ Designated as safety issue: No ]
    Quality of life score


Estimated Enrollment: 300
Study Start Date: July 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tyroserleutide for injection
the Tyroserleutide for injection at the dosage of 6mg/d
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
Placebo Comparator: the placebo 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

Detailed Description:
  • Subjects will return to the hospital 25±5 days after the resection of hepatocellular carcinoma following the baseline examination. Baseline imaging data will be sent to the lead study site imaging center for review and verification. The investigator will determine whether the subject satisfies all inclusion/exclusion criteria. If all requirements are satisfied, then randomization will occur 25±5 days after surgery
  • The day of randomization will be defined as Day 0. Randomized subjects will return to the hospital and begin cycle 1 on the day of randomization (Day 0). The Investigator will administer chemotherapy according to the subject's condition. On the next day, experimental drug therapy will begin, and the relevant laboratory tests will be performed within 3 days after the end the study drug infusion.
  • Cycles will occur every four weeks for the first 6 cycles (i.e. cycles 2, 3, 4, 5, and 6 will begin on days 28 ± 3, 56 ± 3, 84 ± 3, 112 ± 3, and 140 ± 3, respectively). The second 6 cycles will occur every eight weeks (i.e. cycles 7, 8, 9, 10, and 11, will begin on days 196 ± 3, 252 ± 3, 308 ± 3, 364 ± 3, and 420 ± 3, respectively).
  • the participant will receive medical inspection so as to observe and ensure drug safety.
  • A CT scan will be performed for each participant to exclude the recurrence or metastasis of tumor and assess the effects of treatment once before the initiation of each new cycle.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Perioperative Period Inclusion Criteria

  1. Signed informed consent;
  2. Aged ≥ 18 years and ≤ 75 years old, male or female;
  3. Subject underwent a complete resection of hepatocellular carcinoma (confirmed by pathology);
  4. 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

Perioperative Period Exclusion Criteria

  1. Concomitant malignant primary tumor(s) in other systems is/are present;
  2. Tumor thrombosis in the main branch of portal vein or in hepatic vein is detected by preoperative imaging or observed during the surgery;
  3. 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;
  4. The subject took other study/investigational drugs 7 days prior to the resection surgery;
  5. The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases;
  6. The subject has history of study drug or similar drug allergy

Baseline (Post-SurgeryDay 25 ± 5) Inclusion Criteria

  1. Baseline (post-resection) liver CT (normal CT + contrast enhanced CT) and chest CT scan show no tumor lesions;
  2. Child-Pugh score of class A at baseline

Baseline (Post-SurgeryDay 25 ± 5) Exclusion Criteria

  1. Body surface area is < 1.47 m2 or > 1.92 m2;
  2. Concomitant malignant primary tumor(s) in other systems is/are present;
  3. The subject took other study/investigational drugs within 4 weeks prior to randomization;
  4. The baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present;
  5. The baseline examination suggests the presence of tumor metastasis;
  6. The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases;
  7. The subject has history of investigational drug or similar drug allergy;
  8. The subject is pregnant, lactating, or urine pregnancy test result is positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489566

Locations
China, Shanghai
Fudan University Zhongshan Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Fudan University
Medpace, Inc.
Investigators
Study Chair: Tang ZhaoYou, Academician Fudan University Zhongshan Hospital
Study Chair: Wu Meng Chao, Academician Second Milliary Medical University,Eastern Hepatobiliary Surgery Hosipital
Study Director: Fan Jia, professor Fudan University Zhongshan Hospital
Study Director: Yang Jia Mei, professor Second Milliary Medical University,Eastern Hepatobiliary Surgery Hosipital
Principal Investigator: Sun Hui Chuan, professor Fudan University 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
Principal Investigator: Ying Min Gang, professor Fujian Cancer Hospital
Principal Investigator: Shi Xue Tao, professor Shandong Provincial Cancer Hospital
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
Principal Investigator: Ma Kuan Sheng, professor Southwest hospital
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 Jiangsu Province Hospital
Principal Investigator: Ding Yi Tao, professor Nanjing Drum Tower Hospital
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
  More Information

No publications provided

Responsible Party: Shenzhen Kangzhe Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01489566     History of Changes
Other Study ID Numbers: TYS-CN-1.1PUMP III
Study First Received: December 1, 2011
Last Updated: December 13, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Shenzhen Kangzhe Pharmaceutical Co., Ltd.:
Hepatocellular,Carcinoma,recurrence

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Fluorouracil
Mitomycins
Mitomycin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014