Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced HCC

Study Overview
=================
Brief Summary
-----------------
Immuncell-LC in aspects of therapeutic efficacy and safety when administered with Nexavar to advanced Hepatocellular carcinoma patients when compared with the control group who did not receive administration of the drug.

Detailed Description
-----------------
primary outcome Compare clinical efficacy of group treated with cell therapeutic Immuncell-LC evaluated by progression free survival with that of untreated group secondary outcome compare clinical efficacy of group treated with Immuncell-LC, a drug for treating advanced hepatocellular carcinoma evaluated by overall survival, disease control rate, changes of Alpha Feto Protein(AFP) figures from baseline to the last observation date and that of untreated group and evaluate adverse reactions, clinical pathological tests and its safety.

Official Title
-----------------
Randomized, Open-label and Multi-center Clinical Trial to Evaluate the Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced Hepatocellular Carcinoma

Conditions
-----------------
Advanced Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Immuncell-LC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have consented to the study by providing signature of self, guardian or legal representative The patient is more than 20 and less than 80 years old The patient is diagnosed as hepatocellular carcinoma by pathological/radiological test and in the stage of III or IV Child-Pugh Score should be A ECOG Performance Status (ECOG-PS) is less than 2 or equal to Patients who receiving or ready for Nexavar treatment Patients who satisfy the following conditions of the blood test and kidney function test Absolute granulocyte count is bigger than 1,000/µL Hemoglobin is bigger than 8.5 g/dL Platelet count is bigger than 5x10^10/L Blood Urea Nitrogen(BUN) or Creatinine 1.5xupper normal limit Exclusion Criteria: Patients who are immune deficient or have a history of auto-immune diseases (Ex. Rheumatoid Arthritism, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.) Patients who have a history of malignant tumors in the recent 5 years prior to the study with the exception of basal cell carcinoma, local prostate cancer, and cervical cancer, liver cancer. Patients who had anti-cancer medication before the study with the exception of Nexavar Patients who has serious dysfunction in other organs by sub-investigator's opinion Patients has serious allergic-history by sub-investigator's opinion Patients has serious mental disease sub-investigator's opinion Pregnant women, nursing mother of having intention of being pregnant during the study Patients who participated in other clinical trial within 4 weeks before this study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: control group<br>The study subjects randomly assigned to the control group is given Nexavar chemotherapy according to the clinical test plans. | |
| Experimental: Immuncell-LC group<br>The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after baseline by administering Nexavar chemotherapy same as control group with Immuncell-LC (10 times). | Drug: Immuncell-LC<br>* intravenous dripping of 200ml(10^9 2x10^10 lymphocytes/60kg adult) for 1 hour<br>* Other names: Activated T lymphocyte;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess progression-free survival (PFS) | CT, PET-CT, MRI | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the overall survival (OS) |  | up to 2 years | 
| To evaluate the Disease control rate | to determine response rate (CR, PR, SD rate) from the baseline to the late observation date using mRECIST | up to 2 years | 
| To assess the changes of Alpha Feto Protein(AFP)figures from baseline to the last observation date | analysing the changes of AFP before and after combination Nexavar plus Immuncell-LC | up to 2 years | 
| Number of participants with adverse events |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immuncell-LC, advanced hepatocellular carcinoma