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

NCT00644020 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2008-03-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Shenzhen Kangzhe Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chen X P, Professor · Tongji Medical College of Huazhong University of ScienceTechnology

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00644020 on ClinicalTrials.gov