Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02856815
Recruitment Status : Active, not recruiting
First Posted : August 5, 2016
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Green Cross Cell Corporation

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Biological: Immuncell-LC Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

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



Primary Outcome Measures :
  1. Recurrence Free Survival (RFS) [ 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 ]
    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


Secondary Outcome Measures :
  1. Overall Survival (OS) [ 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 ]
    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

  2. Change of Alpha Feto Protein (AFP) level [ 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 ]
    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

  3. Correlation of between Myeloid-derived Suppressor Cell change and Prognosis [ Time Frame: 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

  4. Adverse event [ 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 ]
    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

  5. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) [ Time Frame: 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

  6. Hematological examination [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856815


Locations
Layout table for location information
Korea, Republic of
Seoul St.Mary's Hospital
Seoul, Banpo-daero 222 / Seocho-go, Korea, Republic of, 06591
Seoul National University Hospital
Seoul, Daehak-ro 101/Jongno-gu, Korea, Republic of, 03080
Severance Hospital
Seoul, Seoul,50-1 Yonsei-ro/Seodaemun-gu, Korea, Republic of, 03722
Sponsors and Collaborators
Green Cross Cell Corporation
Investigators
Layout table for investigator information
Principal Investigator: Jung Hwan Yoon, MD Seoul National University Hospital
Layout table for additonal information
Responsible Party: Green Cross Cell Corporation
ClinicalTrials.gov Identifier: NCT02856815    
Other Study ID Numbers: ILC-IIT-05
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Green Cross Cell Corporation:
Immuncell-LC
Transarterial Chemoembolization
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases