Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00921531
First received: June 15, 2009
Last updated: April 18, 2011
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Thalidomide
Drug: TACE
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ⅲ Study of Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    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 Frame: 36 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: June 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thalidomide and TACE
Thalidomide is used for adjuvant therapy for TACE
Drug: Thalidomide

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.

Drug: TACE
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.
Active Comparator: TACE only Drug: TACE
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921531

Contacts
Contact: Zheng-Gang Ren, Ph.D 0086-021-64041990 ext 2137 ren.zhenggang@zs-hospital.sh.cn
Contact: Ju-Bo Zhang, Ph.D 0086-021-64041990 ext 2136 zhang.jubo@zs-hospital.sh.cn

Locations
China, Shanghai
Liver Cancer Institute Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zheng-Gang Ren, Ph.D    0086-021-64041990 ext 2137    ren.zhenggang@zs-hospital.sh.cn   
Contact: Lan Zhang, Master    0086-021-64041990 ext 2171    zhang.lan@zs-hospital.sh.cn   
Principal Investigator: Zheng-Gang Ren, Ph.D         
Sub-Investigator: Jubo Zhang, PhD         
Sponsors and Collaborators
Fudan University
  More Information

Additional Information:
No publications provided

Responsible Party: ethic committee of Zhongshan Hospital of Fudan University, Fudan University
ClinicalTrials.gov Identifier: NCT00921531     History of Changes
Other Study ID Numbers: LCI-THALIDOMIDE, LCI-09-06-15
Study First Received: June 15, 2009
Last Updated: April 18, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
Hepatocellular carcinoma
thalidomide
TACE
Child-Pugh Class A or B

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 01, 2014