Study of Hepatoma Treated by Perfusing Cinobufacin Through Hepatic Artery Combining Embolotherapy
Conditions
Hepatoma - Cinobufacin Injection
Conditions: official terms
Carcinoma, Hepatocellular - Liver Neoplasms
Conditions: Keywords
Transcatheter arterial embolization, Cinobufacin injection, hepatoma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Intervention
Name: Cinobufacin injection
Type: Drug
Overall Status
Recruiting
Summary
Cinobufacini has the effects of anticancer, improving the liver function, elevation of immunity and little side effects, and is important and significant for the patients with hepatitis, liver cirrhosis and hepatomas.

Compared with transarterial chemoembolization (TACE) , the clinical effect of cinobufacini is non-inferior/ equivalent.Compared with TACE, cinobufacini is superior in security .
Detailed Description
Inclusion criterion :

1. The sex does not limit, age:18-70 years old .

2. The patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation< 70 %

3. The patients have failure in surgical intervention or resection operation recidivist

4. Hepatic function Child-pugh A、B

5. All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B ultrasonic or cytology results

6. The patient's prediction of live time>6 months, who can tolerant of TACE and has quality of life ECOG score<3

7. The patients participate the clinical trial voluntarily and have already signed informed consent

Exclusion criterion :

1. Main portal vein was obstructed completely.

2. The occupation of tumor are 70 % or more than 70 % in the whole liver

3. The patient has TACE or other antineoplaston

4. After carcinosectomy the patient has the prophylactic

5. The patient is with renal inadequacy: Cr≥133 umol/L

6. Severe cardiovascular disease

7. The patient is with other diseases to influence the proposal
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. The sex does not limit, age:18-70 years old ;

2. The patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation< 70 %;

3. The patients have failure in surgical intervention or resection operation recidivist;

4. Hepatic function Child-pugh A、B;

5. All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B ultrasonic or cytology results ;

6. The patient's prediction of live time>6 months, who can tolerant of TACE and has quality of life ECOG score<3;

7. The patients participate the clinical trial voluntarily and have already signed informed consent.

Exclusion Criteria:

1. Main portal vein was obstructed completely;

2. The occupation of tumour are 70 % or more than 70 % in the whole liver;

3. The patient has recepted TACE or other antineoplaston;

4. After carcinosectomy the patient has the prophylactic;

5. The patient is with renal inadequacy: Cr≥133 umol/L

6. Severe cardiovascular disease;

7. The patient is with other diseases to influence the proposal;

8. All over the body generally have metabasis or be with other malignant neoplastic disease;

9. In the process of participation of other medicinal trial;

10. Gravidity, lactation ,hypersensitiveness constitution or have already known adverse reaction or taboo.
Location
Department of TCM, Changhai Hospital of Shanghai
Shanghai, Shanghai, China
Status: Recruiting
Contact: changquan Ling, Doctor - +86 21 81873539 - qiaocuixia@126.com
Start Date
November 2010
Completion Date
November 2013
Sponsors
Changhai Hospital
Source
Changhai Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page