A Study of DC-CIK to Treat Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of Dendritic and Cytokine-induced Killer Cells (DC-CIK) for hepatocellular carcinoma (HCC).

Detailed Description
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About 60 patients with HCC, who had received complete resection or TACE and got Complete remission (CR) or partial response (PR), will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.

Official Title
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A Randomized Controlled Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma (HCC)

Intervention / Treatment
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* Biological: Dendritic and Cytokine-induced Killer Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients > 18 years of age; Hepatocellular carcinoma with histological or imaging and AFP diagnose, and had received complete resection or TACE and got CR or PR by imaging studies; Patients who have a life expectancy of at least 12 weeks; Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1; The bone marrow functioned normally (WBC > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L); The ECG results were normal, and the liver and kidney were functional. Exclusion Criteria: Patients who had distant metastases; Patients with uncontrolled infection; underlying disease that was severe or life-threatening; Patients who were pregnant or lactating; ECOG perform status ≥ 2; Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.

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 |
| --- | --- |
| Experimental: A<br>After complete resection or TACE, patients will receive 3 cycles of Dendritic and Cytokine-induced Killer Cells (DC-CIK) (every 4 weeks) | Biological: Dendritic and Cytokine-induced Killer Cells<br> <br> * Other names: DC-CIK;|
| No Intervention: B<br>After complete resection or TACE, Patient only regularly follow up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival(PFS) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival(OS) |  | 1 month | 
| quality of life (QOL) |  | month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, DC-CIK