Study of Hepatoma Treated by Perfusing Cinobufacin Through Hepatic Artery Combining Embolotherapy
Recruitment status was: Recruiting
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 .
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The Clinical Research of the Intermediate and Advanced Hepatoma Treated by Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy|
- The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD. [ Time Frame: Nov. 2010 to Nov. 2013 ] [ Designated as safety issue: Yes ]The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Drug: Cinobufacin injection
Inclusion criterion :
- 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 criterion :
- Main portal vein was obstructed completely.
- The occupation of tumor are 70 % or more than 70 % in the whole liver
- The patient has 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236690
|Department of TCM, Changhai Hospital of Shanghai|
|Shanghai, Shanghai, China, 200433|
|Principal Investigator:||Ling chang quan, doctor||Changhai Hospital|