TACE HCC: Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using TACE With Antiangiogenesis

Sponsor

Southeast University, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT00518557

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate safety and potential therapeutic benefits for patients with hepatocellular carcinoma by transcatheter chemoembolization with the recombinant endostatin (commercially available in China)which is also administrated via the hepatic artery. The hypothesis of this protocol is that TACE with antiangiogenic treatment may inhibit the proangiogenic effects induced by the hypoxia of TACE.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Procedure: Transcatheter Arterial Chemoembolization	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Combination Treatment of TACE With Recombinant Human Endostatin Administrated Via Hepatic Artery in Hepatocellular Carcinoma

Study Start Date :

Apr 1, 2007

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 All patients of this arm are treated by TACE together with Andostatin.	Procedure: Transcatheter Arterial Chemoembolization The interventional procedure is performed as following steps: 1)transcatheter hepatic arterial angiography(including any feeding arteries to the tumor) is performed under a DSA unit; 2) super selectively catheterizaton of feeding arteries to the tumor is reached; 3)30 mg of Andostatin (Simcere Co. China) mixtured with 5 ml Lipiodol is injected into the tumor via the feeding arteries; 4) followed by 10 mg of Epifubicin mixtured with 5 ml of Lipiodol; 5) All feeding arteries to the tumor are occluded which is confirmed by re-angiography. Other Names: TAE
Active Comparator: 2 All patients of this arm are treated by TACE alone: only mixture of Epirubicin and Lipiodol is injected into the feeding arteries of the tumor, without injection of Andostatin.	Procedure: Transcatheter Arterial Chemoembolization The interventional procedure is performed as following steps: 1)transcatheter hepatic arterial angiography(including any feeding arteries to the tumor) is performed under a DSA unit; 2) super selectively catheterizaton of feeding arteries to the tumor is reached; 3)30 mg of Andostatin (Simcere Co. China) mixtured with 5 ml Lipiodol is injected into the tumor via the feeding arteries; 4) followed by 10 mg of Epifubicin mixtured with 5 ml of Lipiodol; 5) All feeding arteries to the tumor are occluded which is confirmed by re-angiography. Other Names: TAE

Arm

Intervention/Treatment

Experimental: 1

All patients of this arm are treated by TACE together with Andostatin.

Procedure: Transcatheter Arterial Chemoembolization

The interventional procedure is performed as following steps: 1)transcatheter hepatic arterial angiography(including any feeding arteries to the tumor) is performed under a DSA unit; 2) super selectively catheterizaton of feeding arteries to the tumor is reached; 3)30 mg of Andostatin (Simcere Co. China) mixtured with 5 ml Lipiodol is injected into the tumor via the feeding arteries; 4) followed by 10 mg of Epifubicin mixtured with 5 ml of Lipiodol; 5) All feeding arteries to the tumor are occluded which is confirmed by re-angiography.

Other Names:

TAE

Active Comparator: 2

All patients of this arm are treated by TACE alone: only mixture of Epirubicin and Lipiodol is injected into the feeding arteries of the tumor, without injection of Andostatin.

Procedure: Transcatheter Arterial Chemoembolization

Other Names:

TAE

Outcome Measures

Primary Outcome Measures

Safety and tolerability, Mortality [6 months]

Secondary Outcome Measures

Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with cytologically or histologically documented HCC, who are candidates for TACE
Child-Pugh Child A or B
Age >= 18
Measurable disease by RECIST criteria;
Performance status ECOG 0-2
Previous local therapy completed > 4 weeks
Written informed consent signed
Normal organ and marrow function defined as:

Haematopoietic:

WBC ≥ 3,000/µlplatelet count > 80,000/mm3
haemoglobin > 9g/dL
Hepatic: Albumin ≥ 2.8 g/dl.serum total bilirubin ≤ 3 mg/dl; AST or ALT < 5 x ULN
Renal: creatinine < 1.5 x ULN