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

Primary Purpose

Hepatocellular Carcinoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Transcatheter Arterial Chemoembolization

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring liver cancer, interventional radiology, Chemoembolization, Safety, Effectiveness

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Interventional Radiology, Zhongda Hospital, Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

All patients of this arm are treated by TACE together with Andostatin.

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.

Outcomes

Primary Outcome Measures

Safety and tolerability, Mortality

Secondary Outcome Measures

Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival

Full Information

NCT ID

NCT00518557

First Posted

August 16, 2007

Last Updated

January 21, 2009

Sponsor

Southeast University, China

1. Study Identification

Unique Protocol Identification Number

NCT00518557

Brief Title

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

Acronym

TACE HCC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

April 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Southeast University, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

liver cancer, interventional radiology, Chemoembolization, Safety, Effectiveness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

All patients of this arm are treated by TACE together with Andostatin.

Arm Title

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Transcatheter Arterial Chemoembolization

Other Intervention Name(s)

TAE

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety and tolerability, Mortality

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiao-Hui Chen, MD

Phone

+86 25 83272121

noriko0706@sohu.com

First Name & Middle Initial & Last Name or Official Title & Degree

Gang Deng, MD, Ph.D

Phone

+86 25 83272118

dmm1996@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gao-Jun Teng, MD, Ph.D

Organizational Affiliation

Zhongda Hospital, Southeast University, Nanjing, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Interventional Radiology, Zhongda Hospital, Southeast University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiao-Hui Chen, MD

Phone

+86 25 83272121

noriko0706@sohu.com

First Name & Middle Initial & Last Name & Degree

Gang Deng, MD

Phone

+86 25 83272118

dmm1996@sina.com

First Name & Middle Initial & Last Name & Degree

Gang Deng, MD, Ph.D

First Name & Middle Initial & Last Name & Degree

Shi-Cheng He, MD

First Name & Middle Initial & Last Name & Degree

Jin-He Guo, MD

12. IPD Sharing Statement

Links:

URL

http://www.ncbi.nlm.nih.gov

Description

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