Status:
COMPLETED
Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced HCC
Lead Sponsor:
GC Cell Corporation
Conditions:
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
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 admin...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01897610
Start Date
December 1 2013
End Date
July 4 2017
Last Update
June 26 2023
Active Locations (4)
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1
Inha University Hospital
Incheon, South Korea, 400-711
2
Yonsei University Health System
Seoul, South Korea, 120-752
3
Korea University Anam Hospital
Seoul, South Korea, 136-750
4
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea, 137-701