Phase ⅡStudy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients - Full Text View

Sponsored by:	Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Information provided by:	Shenzhen Kangzhe Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00644020

Purpose

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.

Condition	Intervention
Hepatocellular Carcinoma	Drug: mitomycin, Fluorouracil

Study Type:	Observational
Study Design:	Case Control, Prospective
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

Resource links provided by NLM:

Drug Information available for: Mitomycin Fluorouracil Mitomycins

U.S. FDA Resources

Further study details as provided by Shenzhen Kangzhe Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

DFS(disease free survival) [ Time Frame: six month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

1.OS （Overall Survival） 2.QOL (quality of life) [ Time Frame: six month ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

collection of blood sample before the operation and ahead of the third and the sixth period.

collection of the tumor tissue during the operation

Estimated Enrollment:	100
Study Start Date:	December 2007
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1 the Tyroserleutide for injection at the dosage of 3mg/d	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.
Group 2 the Tyroserleutide for injection at the dosage of 6mg/d	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.
Group 3 the Tyroserleutide for injection at the dosage of 12mg/d	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.
Group 4 the placebo group	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.

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

HCC complicating branch cork after resection

Criteria

Inclusion Criteria:

Written informed consent
Age between 18 and 75 years
Hepatocellular Carcinoma accompanied with branch vein thrombosis
Carcinoma and bolt resection Integrity, cutting edge no tumor cells by microscopic lens in operation
CTA or MRI no Carcinoma and bolt after operation

Exclusion Criteria:

hypersensitivity to the composition similarity of investigational drug
Concomitance other system primary tumor
surface area 1.47m2～1.92m2
HBV (-) and HCV(-)
Patients who have received resectional surgery for HCC
HCC complicating main portal vein cork
HCC complicating hepatic vein cork
Patients who have received systematicness therapy for HCC
Patients who have received immunoregulant 4 weeks before randomization
Concurrent participation in another clinical trial involving experimental treatment is excluded 4 weeks before randomization
uncontrolled infection, hemorrhage, guts leakage postoperative complications
postoperative liver function Child-pugh C
no evidence of extra-hepatic metastases postoperative
no utility sample for gene chip research
no physical examination, laboratory and imageology examination that baseline request

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644020

Contacts

Contact: Chen X P, professor

027-83662599

chenxp_53@sina.com

Locations

China, GuangDong
a Research Institute of Tumor	Recruiting
Guangzhou, GuangDong, China, 510060
Contact: Weihua Jia , Professor 020-87343370
Sub-Investigator: Yaqi Zhang, Professor

Sponsors and Collaborators

Shenzhen Kangzhe Pharmaceutical Co., Ltd.

Investigators

Principal Investigator:

Chen X P, Professor

Tongji Medical College of Huazhong University of ScienceTechnology

More Information

No publications provided

Responsible Party:	Tongji Hospital of Tongji Medical College of HUST ( Xiaoping Chen )
Study ID Numbers:	TYS-CN-1.1PUMPⅡPartA, TYS-CN-1.1PUMPⅡPartA
Study First Received:	March 23, 2008
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00644020 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Shenzhen Kangzhe Pharmaceutical Co., Ltd.:

Hepatocellular carcinoma
recurrence

Study placed in the following topic categories:

Antimetabolites
Liver Diseases
Digestive System Neoplasms
Immunologic Factors
Carcinoma, Hepatocellular
Immunosuppressive Agents
Mitomycins
Recurrence
Carcinoma
Liver Neoplasms

Anti-Bacterial Agents
Digestive System Diseases
Fluorouracil
Mitomycin
Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular Carcinoma
Alkylating Agents
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Liver Diseases
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Carcinoma, Hepatocellular
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Mitomycins
Liver Neoplasms
Neoplasms by Site
Therapeutic Uses
Mitomycin

Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Digestive System Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Fluorouracil
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009