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

Primary Purpose

Carcinoma, Hepatocellular

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Immuncell-LC
Sponsored by
GC Cell Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Immuncell-LC, Transarterial Chemoembolization

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul St.Mary's Hospital
  • Seoul National University Hospital
  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immuncell-LC group

Non-treatment group

Arm Description

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.

Non-treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 28, 2016
Last Updated
June 19, 2023
Sponsor
GC Cell Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02856815
Brief Title
Safety and Efficacy of "Immuncell-LC" in TACE Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 28, 2018 (Actual)
Primary Completion Date
August 11, 2020 (Actual)
Study Completion Date
September 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GC Cell Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Immuncell-LC, Transarterial Chemoembolization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immuncell-LC group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-treatment group
Arm Type
No Intervention
Arm Description
Non-treatment
Intervention Type
Biological
Intervention Name(s)
Immuncell-LC
Intervention Description
Activated T lymphocyte : intravenous dripping of 200ml (1 x 10^9 ~ 2 x 10^10 lymphocytes / 60kg adult) for 1 hour
Primary Outcome Measure Information:
Title
Recurrence Free Survival (RFS)
Description
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 Outcome Measure Information:
Title
Overall Survival (OS)
Description
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
Title
Change of Alpha Feto Protein (AFP) level
Description
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
Title
Correlation of between Myeloid-derived Suppressor Cell change and Prognosis
Description
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
Title
Adverse event
Description
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
Title
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Description
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
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
Title
Hematological examination
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Hwan Yoon, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St.Mary's Hospital
City
Seoul
State/Province
Banpo-daero 222 / Seocho-go
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Daehak-ro 101/Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
State/Province
Seoul,50-1 Yonsei-ro/Seodaemun-gu
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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