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

• Sponsor: Changhai Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01236690
• Collaborator: (none)
• Enrollment: 284
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 7.9

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Hepatoma; Cinobufacin Injection	Drug: Cinobufacin injection	Phase 2

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 284 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Clinical Research of the Intermediate and Advanced Hepatoma Treated by Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy
• Study Start Date: Nov 1, 2010
• Anticipated Primary Completion Date: Oct 1, 2013
• Anticipated Study Completion Date: Nov 1, 2013

Outcome Measures

Primary Outcome Measures

1. 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]

   The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of TCM, Changhai Hospital of Shanghai	Shanghai	Shanghai	China	200433

Sponsors and Collaborators

• Changhai Hospital

Investigators

• Principal Investigator: Ling chang quan, doctor, Changhai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01236690
• Other Study ID Numbers: CLing
• First Posted: Nov 9, 2010
• Last Update Posted: Jun 28, 2011
• Last Verified: Oct 1, 2010

• Keywords provided by , ,: Transcatheter arterial embolization; Cinobufacin injection; hepatoma
• Additional relevant MeSH terms: Carcinoma, Hepatocellular; Liver Neoplasms

Study Results

No Results Posted as of Jun 28, 2011