NCT01236690

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 284 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hepatoma
• Cinobufacin Injection

Interventions

Type	Name	Description
DRUG	Cinobufacin injection	Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2010-11-09
• Last updated: 2011-06-28

Locations

1 site across 1 country: China