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

Southeast University, China

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Transcatheter Arterial Chemoembolization

Study type: Interventional

Funder types: Other

Identifiers

NCT00518557

SIMCERE-123456

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Procedure: Transcatheter Arterial Chemoembolization

2

Active Comparator group

Description:

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.

Treatment:

Procedure: Transcatheter Arterial Chemoembolization