Study of Hepatoma Treated by Perfusing Cinobufacin Through Hepatic Artery Combining Embolotherapy

Study Overview
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Brief Summary
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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
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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

Official Title
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The Clinical Research of the Intermediate and Advanced Hepatoma Treated by Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy

Conditions
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Hepatoma, Cinobufacin Injection

Intervention / Treatment
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* Drug: Cinobufacin injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cinobufacin injection|Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter arterial embolization, Cinobufacin injection, hepatoma