A Randomized, Double Blind, Placebo Controled, Multicenter Phase ⅡStudy to Evaluate the Safety and Efficacy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients
18 Years
75 Years
Both
Hepatocellular Carcinoma
Trial Information
A Randomized, Double Blind, Placebo Controled, Multicenter Phase ⅡStudy to Evaluate the Safety and Efficacy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients
- 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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
DFS(disease free survival)
Outcome Time Frame:
six month
Safety Issue:
Yes
Principal Investigator
Chen X P, Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tongji Medical College of Huazhong University of ScienceTechnology
Authority:
China: Food and Drug Administration
Study ID:
TYS-CN-1.1PUMPⅡPartA
NCT ID:
NCT00644020
Start Date:
December 2007
Completion Date:
August 2008
Related Keywords:
- Hepatocellular Carcinoma
- Hepatocellular carcinoma
- recurrence
- Carcinoma
- Carcinoma, Hepatocellular
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