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Carcinoma, HepatocellularPhase 2NCT02856815

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

A Phase 2 study testing Immuncell-LC in people with Carcinoma, Hepatocellular, run by GC Cell Corporation at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Immuncell-LC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
3 sitesSouth Korea
Study dates
28 May 2018to 22 Sep 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Seoul St.Mary's Hospital

    Seoul, Banpo-daero 222 / Seocho-go, 06591

  • Seoul National University Hospital

    Seoul, Daehak-ro 101/Jongno-gu, 03080

  • Severance Hospital

    Seoul, Seoul,50-1 Yonsei-ro/Seodaemun-gu, 03722

Other trials in South Korea

About this study

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

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.

Being tested
Immuncell-LC
Keywords
Immuncell-LC, Transarterial Chemoembolization
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immuncell-LCBiological

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

Study groups in NCT02856815
Study groupRoleWhat they receive
Immuncell-LC groupExperimentalAdjuvant 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.
Receives: Biological: Immuncell-LC
Non-treatment groupNo interventionNon-treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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 (6)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2016 (estimated)
  2. Study start28 May 2018
  3. Primary completion11 Aug 2020
  4. Study completion22 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02856815
Sponsor's protocol ID
ILC-IIT-05
Status last verified
Jun 2023
First submitted
28 Jul 2016
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Immuncell-LC in people with Carcinoma, Hepatocellular, run by GC Cell Corporation at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02856815.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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