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

NCT ID: NCT01236690

Last Updated: 2011-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Interventions

Cinobufacin injection

Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy

Intervention Type: DRUG

Other Intervention Names

Z34020273

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Department of TCM, Shanghai Changhai Hospital

Principal Investigators

Ling chang quan, doctor

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

Department of TCM, Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

changquan Ling, Doctor

Role: primary

qiaocuixia@126.com

+86 21 81873539

Other Identifiers

CLing

Identifier Type: -

Identifier Source: org_study_id