A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection.
- 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.
- 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.