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

March 25, 2008 updated by: Shenzhen Kangzhe Pharmaceutical Co., Ltd.

A Randomized, Double Blind, Placebo Controled, Multicenter Phase ⅡStudy to Evaluate the Safety and Efficacy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • A Research Institute of Tumor
        • Contact:
          • Weihua Jia, Professor
          • Phone Number: 020-87343370
        • Sub-Investigator:
          • Yaqi Zhang, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HCC complicating branch cork after resection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DFS(disease free survival)
Time Frame: six month
six month

Secondary Outcome Measures

Outcome Measure
Time Frame
1.OS （Overall Survival） 2.QOL (quality of life)
Time Frame: six month
six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Kangzhe Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Chen X P, Professor, Tongji Medical College of Huazhong University of ScienceTechnology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

August 1, 2008

Study Completion (Anticipated)

August 1, 2008

Study Registration Dates

First Submitted

March 23, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 26, 2008

Last Update Submitted That Met QC Criteria

March 25, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYS-CN-1.1PUMPⅡPartA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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