Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients After Resection of Liver Cancer

Inclusion Criteria

• Male or female patients > 18 years of age.

• Without any prior anti-cancer therapy.

• Patients who have a life expectancy of at least 12 weeks.

• Patients already had radical resection of HCC.

• Definition of radical resection in this study:

• All tumors were moved out, with a clean resection margin.

• Number of tumors <= 3.

• Without tumor invasion of the main trunk and first branch of the portal vein, or hepatic duct, or hepatic vein.

• No hepatic hilum lymphnode metastasis.

• No distance metastasis.

• Hepatocellular carcinoma with histological diagnose.

• No major post-operative complication.

• Patients who have an ECOG PS of 0, or 1.

• Cirrhotic status of Child-Pugh class A only.

• The following laboratory parameters:

• Platelet count >= 70 x 109/L

• Hemoglobin >= 8.5 g/dL

• Albumin >= 3.5 g/dL

• Total bilirubin <= 25umol/L

• Alanine transaminase (ALT) and AST <= 2.5 x upper limit of normal

• Serum creatinine <= 1.5 x the upper limit of normal

• Prothrombin time (PT) <= 3 seconds above control.

• Patients who give written informed consent.

Exclusion Criteria

• Previous or concurrent cancer that is distinct in primary site or histology from HCC.

• History of cardiac disease.

• Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)

• Known history of human immunodeficiency virus (HIV) infection

• Known Central Nervous System tumors including metastatic brain disease.

• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

• History of organ allograft.

• Known or suspected allergy to the investigational agent or any agent given in association with this trial.

• Pregnant or breast-feeding patients.

• Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.

Excluded therapies and medications, previous and concomitant:

• Prior use of any anti-cancer treatment for HCC, eg. chemotherapy, radiotherapy.

• Antiviral treatment is allowed.