A Study to Evaluate Autologous CIK Cells in Patients With Hepatocellular Carcinoma After TACE, PEIT or RFA

Study Overview
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Brief Summary
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A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of Autologous Cytokine-Induced Killer (CIK) Cell for Patients with Hepatocellular Carcinoma (HCC) after Transarterial Chemoembolization (TACE), Percutaneous Ethanol Injection Therapy (PEIT) or RadioFrequency Ablation (RFA) Therapy.

Official Title
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A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of Autologous Cytokine-Induced Killer (CIK) Cell for Patients With Hepatocellular Carcinoma (HCC) After Transarterial Chemoembolization (TACE), Percutaneous Ethanol Injection Therapy (PEIT) or RadioFrequency Ablation (RFA) Therapy

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Biological: CIK Cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 to 80 years old men and women; HCC diagnosed with typical imaging findings, or confirmed by needle liver biopsy; Patients who are not a transplant candidate; Patients who have no extrahepatic metastasis and are with measurable residual tumor after TACE, PEIT or RFA therapy; Patients who have a life expectancy of at least 6 months; Child-Pugh Class should be A or B; Eastern Cooperative Oncology Group (ECOG) performance status score was 0-3; Patients who have clinical laboratory test results as follows: Absolute neutrophil count ≥ 1,500/µL or White blood cell ≥ 4,000/µL Hemoglobin ≥ 8.5 g/dL Platelet count ≥ 50,000/µL Blood creatinine ≤ 1.5 x upper limit of normal Total bilirubin < 3 x upper limit of normal Albumin ≥ 2.8 g/dL International normalized ratio (INR) / Partial thromboplastin time (PTT) < 1.5 x upper limit of normal Written informed consent. Exclusion Criteria: Patients who have infiltrative or diffuse HCC; Patients who have significant cardiovascular disease such as myocardial infarction occurred within recent 6 months, chronic heart failure or unstable coronary artery disease; Patients who plan to receive systemic chemotherapy or target therapy; Patients with other malignant tumor within the past 5 years before treatment; Pregnant or lactating patients; Patients with hemorrhage/bleeding event; Patients with uncontrolled infections; Known or suspected allergy to the investigational agent or any agent given in association with this trial; Patients who have current Human Immunodeficiency Virus (HIV) or Treponema Pallidum (TP) infection; Patients who are suffering from serious autoimmune disease; Patients who have had long term use of or are using an immunosuppressant; History of organ transplant; Prior use of any anti-cancer treatments within 30 days or 5 half-lives (whichever is longer), except TACE, PEIT and RFA therapy; Patients who have participated in another clinical study and received treatment within 30 days prior to the screening visit; Mental conditions rendering the patient incapable of understanding the nature, scope, and consequences of the study; Other situations that the researchers considered unsuitable for this study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CIK Cell<br>Phase I - Three dose levels escalated according to 3+3 rule Phase II - The recommended dose level according to the results from Phase I | Biological: CIK Cell<br>* Autologous cytokine-induced killer (CIK) cell<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: Presence or absence of Dose-Limiting Toxicity |  | 5 Weeks | 
| Phase II: Disease Control Rate |  | 24 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, Autologous Cytokine-Induced Killer