Clinical trial NCT01236690: Study of Hepatoma Treated by Perfusing Cinobufacin Through Hepatic Artery Combining Embolotherapy
Official title: The Clinical Research of the Intermediate and Advanced Hepatoma Treated by Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatoma
Cinobufacin Injection
Keywords: Transcatheter arterial embolization
Cinobufacin injection
hepatoma
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.
timeFrame: Nov. 2010 to Nov. 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of TCM, Changhai Hospital of Shanghai
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Ling chang quan, doctor
role: PRINCIPAL_INVESTIGATOR
References: