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.