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

• Status: Completed
• Trial end date: 2017-07-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Green Cross Cell Corporation
• Treatments: Sorafenib

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