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

GC Cell

Status and phase: Completed; Phase 2

Conditions: Advanced Hepatocellular Carcinoma

Treatments: Drug: Immuncell-LC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01897610

ILC-IIT-04

Details and patient eligibility

About

"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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

control group

No Intervention group

Description:

The study subjects randomly assigned to the control group is given Nexavar chemotherapy according to the clinical test plans.

Immuncell-LC group

Experimental group

Description:

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).

Treatment:

Drug: Immuncell-LC