CIK Treatment for HCC Patient Underwent Radical Resection

Study Overview
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Brief Summary
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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.

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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Carcinoma, Hepatocellular

Intervention / Treatment
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* Biological: Cytokine-Induced Killer Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients over 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 less than 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 performance status of 0, or 1. Cirrhotic status of Child-Pugh class A only. The following laboratory parameters: 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 ( over grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events 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
Maximum Age: 100 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 |
| --- | --- |
| Experimental: A, CIK<br>Biological/Vaccine: Cytokine-Induced Killer Cells | Biological: Cytokine-Induced Killer Cells<br>* Cytokine-Induced Killer Cells treatment for 4 cycles<br>* Other names: CIK;|
| No Intervention: B, CONTROL<br>Regular follow up with no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence | To evaluate efficacy of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection. | 5-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival | Disease Free Survival | 5 year |