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CompletedNCT02856815Updated Jun 22, 2023

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

A Phase 2 interventional study of Immuncell-LC in Carcinoma, Hepatocellular, sponsored by GC Cell Corporation. Completed at 3 sites in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by GC Cell Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Carcinoma, Hepatocellular

Keywords

  • Immuncell-LC
  • Transarterial Chemoembolization
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 76 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

GC Cell Corporation is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • 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

  • No intervention
    Non-treatment group

    Non-treatment

Interventions

  • BiologicalImmuncell-LC

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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

    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

  6. Hematological examination

    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

07

Study locations

3 sites
  • Seoul St.Mary's Hospital
    Seoul, Banpo-daero 222 / Seocho-go 06591, Korea, Republic of
  • Seoul National University Hospital
    Seoul, Daehak-ro 101/Jongno-gu 03080, Korea, Republic of
  • Severance Hospital
    Seoul, Seoul,50-1 Yonsei-ro/Seodaemun-gu 03722, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02856815
Lead sponsor
GC Cell Corporation
Responsible party
Sponsor
First posted
Aug 5, 2016
Start date
May 28, 2018
Primary completion
Aug 11, 2020
Completion
Sep 22, 2022
Last update
Jun 22, 2023

Study contacts

Jung Hwan Yoon, MD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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