The Clinical Research of the Intermediate and Advanced Hepatoma Treated by Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy
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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.
The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.
Nov. 2010 to Nov. 2013
Yes
Ling chang quan, doctor
Principal Investigator
Changhai Hospital, Second Military Medical University
China:Changhai Hospital ethics committee
CLing
NCT01236690
November 2010
November 2013
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