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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00644020
• Other study ID #: TYS-CN-1.1PUMP?PartA
• Secondary ID: TYS-CN-1.1PUMP?P
• Status: Recruiting
• Phase: N/A
• First received: March 23, 2008
• Last updated: March 25, 2008
• Start date: December 2007
• Est. completion date: August 2008

Study information

• Verified date: December 2007
• Source: Shenzhen Kangzhe Pharmaceutical Co., Ltd.
• Contact: Chen X P, professor
• Phone: 027-83662599
• Email: chenxp_53[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	A Research Institute of Tumor	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Kangzhe Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS(disease free survival)		six month	Yes
Secondary	1.OS (Overall Survival) 2.QOL (quality of life)		six month	Yes