Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma
Information source: Fudan University
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatocellular Carcinoma
Intervention: Thalidomide (Drug); TACE (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Fudan University Overall contact:
Zheng-Gang Ren, Ph.D, Phone: 0086-021-64041990, Ext: 2137, Email: ren.zhenggang@zs-hospital.sh.cn
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.
Clinical Details
Official title: Phase Ⅲ Study of Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall survival (OS), time to progression (TTP),and side effects
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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 3Ã10(9)/L
- Peripheral platelet of or more than 50Ã10(9)/L
- Expected survival time not less than 3 months
- ECOG score 1-2
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
Locations and Contacts
Zheng-Gang Ren, Ph.D, Phone: 0086-021-64041990, Ext: 2137, Email: ren.zhenggang@zs-hospital.sh.cn
Liver Cancer Institute, Shanghai, Shanghai 200032, China; Recruiting
Zheng-Gang Ren, Ph.D, Phone: 0086-021-64041990, Ext: 2137, Email: ren.zhenggang@zs-hospital.sh.cn
Ju-Bo Zhang, Ph.D, Phone: 0086-021-64041990, Ext: 2136, Email: zhang.jubo@zs-hospital.sh.cn
Zheng-Gang Ren, Ph.D, Principal Investigator
Ju-Bo Zhang, Ph.D, Sub-Investigator
Additional Information
Zhongshan Hospital,Fudan University,Shanghai,China Fudan University,Shanghai,China
Starting date: June 2009
Last updated: May 25, 2010
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