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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Shenzhen Kangzhe Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00644020
First Posted: March 26, 2008
Last Update Posted: March 26, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
  Purpose
The investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 4 groups, including 3mg, 6mg, 12mg per day and placebo group. Each group includes 25 subjects, who have hepatic-cellular carcinoma accompanied with branch vein thrombosis. They receive investigational drug 40 days after resection surgery. Each cycle lasts 4 to 6 days with an interval of 29 days in all 6 cycles.

Condition Intervention
Hepatocellular Carcinoma Drug: mitomycin, Fluorouracil

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Randomized, Double Blind, Placebo Controled, Multicenter Phase ⅡStudy to Evaluate the Safety and Efficacy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • DFS(disease free survival) [ Time Frame: six month ]

Secondary Outcome Measures:
  • 1.OS (Overall Survival) 2.QOL (quality of life) [ Time Frame: six month ]

Biospecimen Retention:   Samples With DNA

collection of blood sample before the operation and ahead of the third and the sixth period.

collection of the tumor tissue during the operation


Estimated Enrollment: 100
Study Start Date: December 2007
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
the Tyroserleutide for injection at the dosage of 3mg/d
Drug: mitomycin, Fluorouracil
All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period.
Other Names:
  • mitomycin: serial numbers:071006
  • Fluorouracil: serial numbers:0710071
Group 2
the Tyroserleutide for injection at the dosage of 6mg/d
Drug: mitomycin, Fluorouracil
All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period.
Other Names:
  • mitomycin: serial numbers:071006
  • Fluorouracil: serial numbers:0710071
Group 3
the Tyroserleutide for injection at the dosage of 12mg/d
Drug: mitomycin, Fluorouracil
All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period.
Other Names:
  • mitomycin: serial numbers:071006
  • Fluorouracil: serial numbers:0710071
Group 4
the placebo group
Drug: mitomycin, Fluorouracil
All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period.
Other Names:
  • mitomycin: serial numbers:071006
  • Fluorouracil: serial numbers:0710071

Detailed Description:
  • Patients who have signed the Informed Consent Form and are eligible for the entry criteria will be randomly assigned to either the TYROSERLEUTIDE treatment group or the placebo group. No matter which group the subject is assigned, he/she would receive chemotherapy treatment through the portal vein pump which was transplanted during the carcinoma section surgery 40 days before the randomization.
  • Participants will be given either TYROSERLEUTIDE or placebo through intravenous injection with an interval of 29 days, during which the participant will not take any investigational drug or any other anti-tumor treatment as well. On the day just next to the completion of each cycle of research treatment which usually lasts for 3-5 days, the participant will receive medical inspection so as to observe and ensure drug safety.
  • Participants will continue to receive investigational drug for 6 cycles until being detected with recurrence or metastasis of tumor or experiencing any serious side effects.
  • A CT scan or MRI 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HCC complicating branch cork after resection
Criteria

Inclusion Criteria:

  1. Written informed consent
  2. Age between 18 and 75 years
  3. Hepatocellular Carcinoma accompanied with branch vein thrombosis
  4. Carcinoma and bolt resection Integrity, cutting edge no tumor cells by microscopic lens in operation
  5. CTA or MRI no Carcinoma and bolt after operation

Exclusion Criteria:

  1. hypersensitivity to the composition similarity of investigational drug
  2. Concomitance other system primary tumor
  3. surface area 1.47m2~1.92m2
  4. HBV (-) and HCV(-)
  5. Patients who have received resectional surgery for HCC
  6. HCC complicating main portal vein cork
  7. HCC complicating hepatic vein cork
  8. Patients who have received systematicness therapy for HCC
  9. Patients who have received immunoregulant 4 weeks before randomization
  10. Concurrent participation in another clinical trial involving experimental treatment is excluded 4 weeks before randomization
  11. uncontrolled infection, hemorrhage, guts leakage postoperative complications
  12. postoperative liver function Child-pugh C
  13. no evidence of extra-hepatic metastases postoperative
  14. no utility sample for gene chip research
  15. no physical examination, laboratory and imageology examination that baseline request
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644020


Contacts
Contact: Chen X P, professor 027-83662599 chenxp_53@sina.com

Locations
China, Guangdong
A Research Institute of Tumor Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Weihua Jia , Professor    020-87343370      
Sub-Investigator: Yaqi Zhang, Professor         
Sponsors and Collaborators
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Chen X P, Professor Tongji Medical College of Huazhong University of ScienceTechnology
  More Information

Responsible Party: Xiaoping Chen, Tongji Hospital of Tongji Medical College of HUST
ClinicalTrials.gov Identifier: NCT00644020     History of Changes
Other Study ID Numbers: TYS-CN-1.1PUMPⅡPartA
First Submitted: March 23, 2008
First Posted: March 26, 2008
Last Update Posted: March 26, 2008
Last Verified: December 2007

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

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