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

Phase 3
18 Years
80 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

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

Outcome Time Frame:

36 months

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

April 2013

Related Keywords:

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