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

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

Study hypothesis:

The recurrence rate of HCC patients after radical resection is about 60-70%. This study is based on the hypothesis that CIK treatment could decrease the recurrence rate by 15% to 20%.

Abstract:

This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who underwent radical resection will be included. The patients will be randomized to group A (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer treatment after resection of HCC, and the randomize ratio will be 1:1.

Study treatment:

Patients in group A will receive 4 cycles of CIK treatments within 3 months after their liver resection. Patients in group B will have no anti-cancer therapy. Anti-virus and other supportive therapies are available in both groups.

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.