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

• Status: Unknown status
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd.
• Treatments: Fluorouracil; Mitomycin; Mitomycins

Criteria

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