Clinical trial NCT01897610: Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced HCC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Hepatocellular Carcinoma
Keywords: Immuncell-LC, advanced hepatocellular carcinoma
Lead sponsor: GC Cell Corporation
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To assess progression-free survival (PFS)
timeFrame: up to 2 years
Secondary outcomes:
measure: To assess the overall survival (OS)
timeFrame: up to 2 years
measure: To evaluate the Disease control rate
timeFrame: up to 2 years
measure: To assess the changes of Alpha Feto Protein(AFP)figures from baseline to the last observation date
timeFrame: up to 2 years
measure: Number of participants with adverse events
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Soon Ho Um, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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