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

Naval Military Medical University

Status and phase: Unknown; Phase 2

Conditions: Cinobufacin Injection; Hepatoma

Treatments: Drug: Cinobufacin injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01236690

CLing

Details and patient eligibility

About

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 .

Full 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

Enrollment: 284 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 criteria

1. Main portal vein was obstructed completely;
2. The occupation of tumour are 70 % or more than 70 % in the whole liver;
3. The patient has recepted 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;
8. All over the body generally have metabasis or be with other malignant neoplastic disease;
9. In the process of participation of other medicinal trial;
10. Gravidity, lactation ,hypersensitiveness constitution or have already known adverse reaction or taboo.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind