Status:
UNKNOWN
Phase ⅡStudy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients
Lead Sponsor:
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
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...
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 whic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00644020
Start Date
December 1 2007
End Date
August 1 2008
Last Update
March 26 2008
Active Locations (1)
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1
A Research Institute of Tumor
Guangzhou, Guangdong, China, 510060