Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

Phase 3

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Thalidomide; Drug: TACE

• Registration Number: NCT00921531
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-06
• Study Start: 2009-06
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Last Update Submitted: 2011-04-18
• Last Update Posted: 2011-04-19
• Primary Completion: 2012-12
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thalidomide and TACE	Thalidomide	Thalidomide is used for adjuvant therapy for TACE
TACE only	TACE	-
Thalidomide and TACE	TACE	Thalidomide is used for adjuvant therapy for TACE

Primary Outcome Measures

Name	Time	Method
Overall survival	36 months	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

Name	Time	Method
time to progression	36 months	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.

Trial Locations

Locations (1)

Liver Cancer Institute; 🇨🇳 Shanghai, Shanghai, China