Clinical trial NCT00644020: Phase ⅡStudy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
recurrence
Lead sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HCC complicating branch cork after resection

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: DFS(disease free survival)
timeFrame: six month
Secondary outcomes:
measure: 1.OS （Overall Survival） 2.QOL (quality of life)
timeFrame: six month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: A Research Institute of Tumor
state: Guangdong
Study officials:
affiliation: Tongji Medical College of Huazhong University of ScienceTechnology
name: Chen X P, Professor
role: PRINCIPAL_INVESTIGATOR
References: