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Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Thalidomide

TACE

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, thalidomide, TACE, Child-Pugh Class A or B

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
Age ≥ 18 years and ≤ 80 years
At least one tumor nodule with one uni-dimension of ≥ 2 cm
Child-Pugh Class A or B
Total bilirubin ≤ 1.5 x upper limit of normal
ALT and AST ≤ 2.0 x the upper limit of normal
PT-INR<2.3,PTT < 1.5 x upper limit of normal
Serum creatinine ≤ 1.5x upper limit of normal
Peripheral white blood cell count of or more than 3×10(9)/L
Peripheral platelet of or more than 50×10(9)/L
Expected survival time not less than 3 months
ECOG score 0-2

Exclusion Criteria:

Tumor thrombi in main branch of portal vein
Tumor involvement more than 70% of whole liver
With extrahepatic metastasis
Prior systemic chemotherapy or chemoembolization
Congestive heart failure > NYHA class 2
History of HIV infection
Active clinically serious infections (> 2 NCI-CTC Version 3.0)
Recurrence of HCC after liver transplantation
Pregnant or breast-feeding
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
Known or suspected allergy to any agent given in association with this trial
Patients unable to swallow oral medication
Inclined to thrombosis
Inclined to hemorrhage or active hemorrhage with 1 month

Sites / Locations

Liver Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thalidomide and TACE

TACE only

Arm Description

Thalidomide is used for adjuvant therapy for TACE

Outcomes

Primary Outcome Measures

Overall survival

primary outcome is defined as overall survival. overall survival is calculated from the time of undergo treatment (TACE) to time of patients death.

Secondary Outcome Measures

time to progression

time to progression is defined as from the time of treatment (TACE) to the time of patient's progression. the progression is defined as disease progression based on RECIST criteria.

Full Information

NCT ID

NCT00921531

First Posted

June 15, 2009

Last Updated

April 18, 2011

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT00921531

Brief Title

Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

Official Title

Phase Ⅲ Study of Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Unknown status

Study Start Date

June 2009 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

April 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Chemoembolization (TACE) is used in the majority of advanced hepatocellular carcinomas. Randomized clinical trials indicated that TACE improves overall survival in patients with good liver function (Child-pugh A or B). However, the shortcoming of TACE is obvious: hypoxia induced neoangiogenesis after blockage of blood supply of the tumor; repeat TACE deteriorates liver cirrhosis due to toxicity of chemotherapeutic agent to the parenchyma liver. Thalidomide has been reported to have antiangiogenic and antimetastatic effects. The objectives of adjuvant therapy with thalidomide for chemoembolization is to evaluate overall survival and time to progression.

6. Conditions and Keywords

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

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma, thalidomide, TACE, Child-Pugh Class A or B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Thalidomide and TACE

Arm Type

Experimental

Arm Description

Thalidomide is used for adjuvant therapy for TACE

Arm Title

TACE only

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Thalidomide

Intervention Description

Thalidomide is used for adjuvant therapy for TACE Thalidomide will be given at the dose of 200 mg/day in beginning, with dose escalation of 100 mg/day each week, until to the dosage of 400 mg/day.

Intervention Type

Drug

Intervention Name(s)

TACE

Intervention Description

TACE (5-FU 1.0 g, OXP 150mg, MMC 10 mg, lipiodol 5-30 ml) will be performed every two months (defined as a course) until no radiological evidence of survival of tumor (based on contrast MRI) or 6 courses.

Primary Outcome Measure Information:

Title

Overall survival

Description

primary outcome is defined as overall survival. overall survival is calculated from the time of undergo treatment (TACE) to time of patients death.

Time Frame

36 months

Secondary Outcome Measure Information:

Title

time to progression

Description

time to progression is defined as from the time of treatment (TACE) to the time of patient's progression. the progression is defined as disease progression based on RECIST criteria.

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features Age ≥ 18 years and ≤ 80 years At least one tumor nodule with one uni-dimension of ≥ 2 cm Child-Pugh Class A or B Total bilirubin ≤ 1.5 x upper limit of normal ALT and AST ≤ 2.0 x the upper limit of normal PT-INR<2.3,PTT < 1.5 x upper limit of normal Serum creatinine ≤ 1.5x upper limit of normal Peripheral white blood cell count of or more than 3×10(9)/L Peripheral platelet of or more than 50×10(9)/L Expected survival time not less than 3 months ECOG score 0-2 Exclusion Criteria: Tumor thrombi in main branch of portal vein Tumor involvement more than 70% of whole liver With extrahepatic metastasis Prior systemic chemotherapy or chemoembolization Congestive heart failure > NYHA class 2 History of HIV infection Active clinically serious infections (> 2 NCI-CTC Version 3.0) Recurrence of HCC after liver transplantation Pregnant or breast-feeding Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study Known or suspected allergy to any agent given in association with this trial Patients unable to swallow oral medication Inclined to thrombosis Inclined to hemorrhage or active hemorrhage with 1 month

Central Contact Person:

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

Zheng-Gang Ren, Ph.D

Phone

0086-021-64041990

Ext

2137

ren.zhenggang@zs-hospital.sh.cn

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

Ju-Bo Zhang, Ph.D

Phone

0086-021-64041990

Ext

2136

zhang.jubo@zs-hospital.sh.cn

Facility Information:

Facility Name

Liver Cancer Institute

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zheng-Gang Ren, Ph.D

Phone

0086-021-64041990

Ext

2137

ren.zhenggang@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Lan Zhang, Master

Phone

0086-021-64041990

Ext

2171

zhang.lan@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Zheng-Gang Ren, Ph.D

First Name & Middle Initial & Last Name & Degree

Jubo Zhang, PhD

12. IPD Sharing Statement

Links:

URL

http://www.fudan.edu.cn/

Description

Fudan University,Shanghai,China

Learn more about this trial

Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

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