Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: TACE; Drug: Thalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT00921531

LCI-THALIDOMIDE

LCI-09-06-15

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Thalidomide and TACE

Experimental group

Description:

Thalidomide is used for adjuvant therapy for TACE

Treatment:

Drug: Thalidomide

Drug: TACE

TACE only

Active Comparator group

Treatment:

Drug: TACE