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

Randomized, Open-label, Multi-center and Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in the Patients Undergone TACE for Intermediate Stage Hepatocellular Carcinoma

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

Study Overview

• Status: Completed
• Conditions: Carcinoma, Hepatocellular
• Intervention / Treatment: Biological: Immuncell-LC

Detailed Description

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
• Enrollment (Actual): 76
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Banpo-daero 222 / Seocho-go
    • Seoul, Banpo-daero 222 / Seocho-go, Korea, Republic of, 06591
      • Seoul St.Mary's Hospital
  • Daehak-ro 101/Jongno-gu
    • Seoul, Daehak-ro 101/Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital
  • Seoul,50-1 Yonsei-ro/Seodaemun-gu
    • Seoul, Seoul,50-1 Yonsei-ro/Seodaemun-gu, Korea, Republic of, 03722
      • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immuncell-LC group; Adjuvant adoptive immune therapy using a CIK cell agent(Immuncell-LC) 12 times(5 treatments at a frequency of once per week, followed by 5 treatments every 2 weeks, and finally 2 treatments every 4 weeks.	Biological: Immuncell-LC; Activated T lymphocyte : intravenous dripping of 200ml (1 x 10^9 ~ 2 x 10^10 lymphocytes / 60kg adult) for 1 hour
No Intervention: Non-treatment group; Non-treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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)	From the time the patient provided written informed consent until drop-out or the end of the study or 4 weeks after the last dose of immunotherapy	From the time the patient provided written informed consent until drop-out or the end of the study or 4 weeks after the last dose of immunotherapy
Hematological examination	Every 12 weeks from the baseline until 4 weeks after the last dose of immunotherapy	Every 12 weeks from the baseline until 4 weeks after the last dose of immunotherapy

Collaborators and Investigators

• Sponsor: GC Cell Corporation
• Investigators: Principal Investigator: Jung Hwan Yoon, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Actual): August 11, 2020
• Study Completion (Actual): September 22, 2022

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimated): August 5, 2016

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Transarterial Chemoembolization; Immuncell-LC
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: ILC-IIT-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No