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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Southeast University, China.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Southeast University, China
ClinicalTrials.gov Identifier:
NCT00518557
First received: August 16, 2007
Last updated: January 21, 2009
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention
Hepatocellular Carcinoma
 Procedure: Transcatheter Arterial Chemoembolization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Combination Treatment of TACE With Recombinant Human Endostatin Administrated Via Hepatic Artery in Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Southeast University, China:

Primary Outcome Measures:
  • Safety and tolerability, Mortality [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival [ Time Frame: 2 years ]

Estimated Enrollment: 60
Study Start Date: April 2007
Estimated Study Completion Date: December 2009
Arms Assigned Interventions
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 Name: 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 Name: TAE

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518557

Contacts
Contact: Xiao-Hui Chen, MD +86 25 83272121 noriko0706@sohu.com
Contact: Gang Deng, MD, Ph.D +86 25 83272118 dmm1996@sina.com

Locations
China, Jiangsu
Department of Interventional Radiology, Zhongda Hospital, Southeast University Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Xiao-Hui Chen, MD     +86 25 83272121     noriko0706@sohu.com    
Contact: Gang Deng, MD     +86 25 83272118     dmm1996@sina.com    
Sub-Investigator: Gang Deng, MD, Ph.D            
Sub-Investigator: Shi-Cheng He, MD            
Sub-Investigator: Jin-He Guo, MD            
Sponsors and Collaborators
Southeast University, China
Investigators
Principal Investigator: Gao-Jun Teng, MD, Ph.D Zhongda Hospital, Southeast University, Nanjing, China
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00518557     History of Changes
Other Study ID Numbers: SIMCERE-123456
Study First Received: August 16, 2007
Last Updated: January 21, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Southeast University, China:
liver cancer
interventional radiology
Chemoembolization
Safety
Effectiveness

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Liver Diseases
Endostatins
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013