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

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Immuncell-LC group	Immuncell-LC	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).

Primary Outcome Measures

Name	Time	Method
To assess progression-free survival (PFS)	up to 2 years	CT, PET-CT, MRI

Secondary Outcome Measures

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

Locations (4): Korea University Anam Hospital
🇰🇷
Seoul, Korea, Republic of
Inha University Hospital
🇰🇷
Incheon, Korea, Republic of
Yonsei University Health System
🇰🇷
Seoul, Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital
🇰🇷
Seoul, Korea, Republic of

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