Title

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

    N/A
  • Study Type

    Observational
  • Status

    Unknown status
  • Study Participants

    100
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.
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 Started
Dec 31
2007
Primary Completion
Aug 31
2008
Anticipated
Study Completion
Aug 31
2008
Anticipated
Last Update
Mar 26
2008
Estimate

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 1 None

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

Group 2 None

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

Group 3 None

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

Group 4 None

the placebo group

Population

HCC complicating branch cork after resection

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted