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

January 21, 2009 updated by: Southeast University, China

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Department of Interventional Radiology, Zhongda Hospital, Southeast University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Gang Deng, MD, Ph.D
        • Sub-Investigator:
          • Shi-Cheng He, MD
        • Sub-Investigator:
          • Jin-He Guo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability, Mortality
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Investigators

  • Principal Investigator: Gao-Jun Teng, MD, Ph.D, Zhongda hospital, Southeast university, Nanjing, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

August 16, 2007

First Submitted That Met QC Criteria

August 17, 2007

First Posted (Estimate)

August 20, 2007

Study Record Updates

Last Update Posted (Estimate)

January 22, 2009

Last Update Submitted That Met QC Criteria

January 21, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIMCERE-123456

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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