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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Biological: cytokine-induced killer cell (CIK) treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: B (control group)<br>regular treatment and follow up | |
| Experimental: A (CIK group)<br>cytokine-induced killer cell treatment plus regular treatment and follow up | Biological: cytokine-induced killer cell (CIK) treatment<br>* cytokine-induced killer cell treatment every two weeks, for 4 cycles<br>* Other names: CIK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence (TTR) |  | month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | month | 
| Progression Free Survival (PFS) |  | month | 
| Laboratory findings |  | every 3 months | 
| AEs and SAEs |  | monthly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, recurrent, cytokine-induced killer cell