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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Transcatheter Arterial Chemoembolization


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Metastases Prior or concomitant chemotherapy or radiation therapy VEGF/VEGFR- inhibitors or other anti-angiogenesis agents Severe and/or uncontrolled medical conditions: Congestive heart failure, serious cardiac arrhythmia, active coronary artery Severe renal impairment Patients who anticipate receiving major surgery during the course of the Pregnant or breastfeeding patients Evidence of bleeding diathesis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>All patients of this arm are treated by TACE together with Andostatin. | Procedure: Transcatheter Arterial Chemoembolization<br>* 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.<br>* Other names: TAE;|
| Active Comparator: 2<br>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<br>* 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.<br>* Other names: TAE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability, Mortality |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver cancer, interventional radiology, Chemoembolization, Safety, Effectiveness