Safety and Efficacy of "Immuncell-LC" in TACE Therapy

GC Cell Corporation76 enrolled

Overview

To evaluate the efficacy and safety of 'Immuncell-LC group' and 'non-treatment group' in the patients undergone Transarterial Chemoembolization for intermediate stage hepatocellular carcinoma

ILC-IIT-05 is randomized, open-label, multi-center phase 2 clinical trial. To confirm clinical efficacy and safety between 'Immuncell-LC group' and 'non-treatment group', primary outcome, recurrence free survival(RFS) will be evaluated. For secondary outcome, overall survival(OS), changes of Alpha Feto Protein(AFP), correlation of between myeloid-derived suppressor cell change and prognosis, adverse event, ECOG-PS and hematological examination will be evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Hepatocellular

Interventions

Immuncell-LCBIOLOGICAL

Activated T lymphocyte : intravenous dripping of 200ml (1 x 10\^9 \~ 2 x 10\^10 lymphocytes / 60kg adult) for 1 hour

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who have consented to the study by providing signature of self * Patients who are more than 20 and less than 80 years old * Child-Pugh Class should be A(score 5-6) or B(score 7-8) * ECOG Performance Status (ECOG-PS) score is less than 1 or equal to * Patients who have been diagnosed with BCLC stage B hepatocellular carcinoma by pathological/radiological test(Dynamic contrast-enhanced CT or Dynamic MRI) and tumor removal has been confirmed after TACE (When patients have been diagnosed with recurrence of hepatocellular carcinoma after surgery or local treatment, if conditions are same as above, patients could be included) * Patients who satisfy the following conditions of the blood test and kidney, liver function test * Absolute neutrophil count \> 500/µL * Hemoglobin ≥ 8.5 g/dL * Platelet count \> 50,000/µL * Blood Creatinine ≤ 1.5xupper normal limit * Total bilirubin \< 3mg/dL * Albumin ≥ 2.8g/dL Exclusion Criteria: * Patients who have been confirmed with residual tumor or extrahepatic metastases * Patients who have lymph node metastases or portal vein, hepatic vein invasion * Patients who have a history of treatments or are in conditions as below * Liver transplantation * From Informed consent form sign date, systemic chemotherapy in 4 weeks or ongoing adverse drug reactions from anticancer drug in 6 weeks * External beam radiation, immunotherapy, molecular target therapy * More than 2 times of systemic chemotherapy * Biliary reconstruction or endoscopic biliary treatment * Patients who have a history of auto-immune diseases (Ex. Rheumatoid Arthritis, 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 except hepatocellular carcinoma * Patients who participated in another clinical trial and conducted treatment in 4 weeks or have a plan for administration of another clinical trial treatment since Informed consent form sign date * Patients who have uncontrollable or serious disease * Pregnant women or nursing mother * Patients who intend to get pregnant during the study

Locations (3)

Seoul St.Mary's Hospital

Seoul, Banpo-daero 222 / Seocho-go, South Korea

Seoul National University Hospital

Seoul, Daehak-ro 101/Jongno-gu, South Korea

Severance Hospital

Seoul, Seoul,50-1 Yonsei-ro/Seodaemun-gu, South Korea

Outcomes

Primary Outcomes

Recurrence Free Survival (RFS)

Every 12 weeks from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject

Time frame: baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject

Secondary Outcomes

Overall Survival (OS)

Every 12 weeks from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject

Time frame: baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject

Change of Alpha Feto Protein (AFP) level

Every 12 weeks from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject

Time frame: Every 12 weeks from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject

Correlation of between Myeloid-derived Suppressor Cell change and Prognosis

Every 12 weeks from the baseline until 4 weeks after the last dose of immunotherapy

Time frame: Every 12 weeks from the baseline until 4 weeks after the last dose of immunotherapy

Adverse event

From the time the patient provided written informed consent until drop-out or the end of the study or at least 4 weeks after the last dose of immunotherapy

Time frame: From the time the patient provided written informed consent until drop-out or the end of the study or at least 4 weeks after the last dose of immunotherapy

Eastern Cooperative Oncology Group Performance Status (ECOG-PS)

Data from ClinicalTrials.gov

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