Status:
UNKNOWN
Study of Hepatoma Treated by Perfusing Cinobufacin Through Hepatic Artery Combining Embolotherapy
Lead Sponsor:
Changhai Hospital
Conditions:
Hepatoma
Cinobufacin Injection
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 cirrhos...
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 pa...
Eligibility Criteria
Inclusion
- The sex does not limit, age:18-70 years old ;
- The patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation\< 70 %;
- The patients have failure in surgical intervention or resection operation recidivist;
- Hepatic function Child-pugh A、B;
- All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B ultrasonic or cytology results ;
- The patient's prediction of live time\>6 months, who can tolerant of TACE and has quality of life ECOG score\<3;
- The patients participate the clinical trial voluntarily and have already signed informed consent.
Exclusion
- Main portal vein was obstructed completely;
- The occupation of tumour are 70 % or more than 70 % in the whole liver;
- The patient has recepted TACE or other antineoplaston;
- After carcinosectomy the patient has the prophylactic;
- The patient is with renal inadequacy: Cr≥133 umol/L
- Severe cardiovascular disease;
- The patient is with other diseases to influence the proposal;
- All over the body generally have metabasis or be with other malignant neoplastic disease;
- In the process of participation of other medicinal trial;
- Gravidity, lactation ,hypersensitiveness constitution or have already known adverse reaction or taboo.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT01236690
Start Date
November 1 2010
End Date
November 1 2013
Last Update
June 28 2011
Active Locations (1)
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1
Department of TCM, Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China, 200433