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

NCT00518557 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-01-22

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Southeast University, China

    lead OTHER

Principal Investigators

  • Gao-Jun Teng, MD, Ph.D · Zhongda Hospital, Southeast University, Nanjing, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Completion
2009-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00518557 on ClinicalTrials.gov