NCT00644020

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

March 26, 2008

Status Verified

December 1, 2007

Enrollment Period

8 months

First QC Date

March 23, 2008

Last Update Submit

March 25, 2008

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomarecurrence

Outcome Measures

Primary Outcomes (1)

  • DFS(disease free survival)

    six month

Secondary Outcomes (1)

  • 1.OS （Overall Survival） 2.QOL (quality of life)

    six month

Study Arms (4)

Group 1

the Tyroserleutide for injection at the dosage of 3mg/d

Drug: mitomycin, Fluorouracil

Group 2

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

Drug: mitomycin, Fluorouracil

Group 3

the Tyroserleutide for injection at the dosage of 12mg/d

Drug: mitomycin, Fluorouracil

Group 4

the placebo group

Drug: mitomycin, Fluorouracil

Interventions

mitomycin, FluorouracilDRUG

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.

Also known as: mitomycin: serial numbers:071006, Fluorouracil: serial numbers:0710071
Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HCC complicating branch cork after resection

You may qualify if:

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

You may not qualify if:

  • hypersensitivity to the composition similarity of investigational drug
  • Concomitance other system primary tumor
  • surface area 1.47m2～1.92m2
  • HBV (-) and HCV(-)
  • Patients who have received resectional surgery for HCC
  • HCC complicating main portal vein cork
  • HCC complicating hepatic vein cork
  • Patients who have received systematicness therapy for HCC
  • Patients who have received immunoregulant 4 weeks before randomization
  • Concurrent participation in another clinical trial involving experimental treatment is excluded 4 weeks before randomization
  • uncontrolled infection, hemorrhage, guts leakage postoperative complications
  • postoperative liver function Child-pugh C
  • no evidence of extra-hepatic metastases postoperative
  • no utility sample for gene chip research
  • no physical examination, laboratory and imageology examination that baseline request

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A Research Institute of Tumor

Guangzhou, Guangdong, 510060, China

RECRUITING

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

MeSH Terms

Conditions

Carcinoma, HepatocellularRecurrence

Interventions

MitomycinFluorouracil

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingUracilPyrimidinonesPyrimidines

Study Officials

  • Chen X P, Professor

    Tongji Medical College of Huazhong University of ScienceTechnology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen X P, professor

CONTACT

027-83662599chenxp_53@sina.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 23, 2008

First Posted

March 26, 2008

Study Start

December 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

March 26, 2008

Record last verified: 2007-12

Locations

CN(1)