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

Not Applicable

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT00518557
• Lead Sponsor: Southeast University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-08-16
• Study First Submitted QC: 2007-08-17
• Study First Posted: 2007-08-20
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-21
• Last Update Posted: 2009-01-22
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and tolerability, Mortality	6 months

Secondary Outcome Measures

Name	Time	Method
Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival	2 years

Trial Locations

Locations (1)

Department of Interventional Radiology, Zhongda Hospital, Southeast University; 🇨🇳 Nanjing, Jiangsu, China