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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Southeast University, China.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00518557
First Posted: August 20, 2007
Last Update Posted: January 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Southeast University, China
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Combination Treatment of TACE With Recombinant Human Endostatin Administrated Via Hepatic Artery in Hepatocellular Carcinoma

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00518557     History of Changes
Other Study ID Numbers: SIMCERE-123456
First Submitted: August 16, 2007
First Posted: August 20, 2007
Last Update Posted: January 22, 2009
Last Verified: January 2009

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