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

Hepatoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01236690
• Other study ID #: CLing
• Status: Recruiting
• Phase: Phase 2
• First received: November 8, 2010
• Last updated: June 27, 2011
• Start date: November 2010
• Est. completion date: November 2013

Study information

• Verified date: October 2010
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:Changhai Hospital ethics committee
• Study type: Interventional

Clinical Trial 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 .

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 284
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cinobufacin Injection
• Hepatoma
• Liver Neoplasms

Intervention

Drug:
• Cinobufacin injection
Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy

Locations

Country	Name	City	State
China	Department of TCM, Changhai Hospital of Shanghai	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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