Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular carcinoma, recurrence
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.
Interventions
DRUGmitomycin, 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.
Sponsors
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS(disease free survival) | six month |
Secondary
| Measure | Time frame |
|---|---|
| 1.OS （Overall Survival） 2.QOL (quality of life) | six month |
Countries
China
Contacts
Primary ContactChen X P, professor
Outcome results
None listed