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Completed

NCT Number: NCT03983967

Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation

The purpose of this study is to investigate and validate the maximum tolerated dose (MTD) or maximum available dose (MFD), safety and efficacy on patients with hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation.

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Key information

Conditions

Liver Transplantation

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Seoul National Hospital

Seoul, 110-744, South Korea

About this study

ILC-IIT-07 is open-label, phase 1/2 clinical trial to confirm safety on patients with hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation. For primary outcome, maximum feasible dose (MFD) or maximum tolerated dose (MTD) will be evaluated.

For secondary outcome, Time to Recurrence(TTR), Recurrence-Free Survival(RFS), Overall Survival(OS) will be evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are more than 20 and less than 80 years old.
  • Patients whose expected life expectancy is at least 16 weeks (4 months).
  • Patients who receive liver transplants exceeding the Milan Criteria.
  • ECOG Performance Status (ECOG-PS) score is 0-2.
  • Patients who satisfy the following conditions of the blood test and kidney, liver function test.

Absolute neutrophil count > 500x10^6L Hemoglobin ≥ 7.5 g/dL Platelet count > 20,000/㎣ Total bilirubin < 15mg/㎗

•Patients who have agreed to participate in the study voluntarily by signing on informed consent form.

Exclusion criteria

  • Patients who have received in vitro radiation therapy, systemic chemotherapy within 4 weeks based on sign date of Informed consent form.
  • Patients who undergo ABO incompatible Liver Transplantation.
  • Patients who had previously administered cell therapy.
  • Patients who are confirmed with Acquired Immune Deficiency Syndrome (AIDS).
  • Patients who are currently receiving dialysis.
  • Patients who participated in another clinical trial and received 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.
  • Patients who are unable to use appropriate methods of contraception during the study period.
  • Patient whose tumor has not been removed or liver metastasis is confirmed.

Treatment and study plan

Immuncell-LC

Biological

Activated T lymphocyte

Primary outcomes

  1. maximum tolerated dose (MTD) or maximum feasible dose (MFD)

    Time frame: Every visit 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

    The observation of maximum tolerated dose (MTD) or maximum feasible dose (MFD) evaluation(1X10^7cell, 5X10^7cell, 10X10^7cells) of immuncell-LC on hepatocellular carcinoma patients who undergo liver transplantation

Secondary outcomes

  1. Time to Recurrence

    Time frame: Every visit 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 to Recurrence is defined as the recurring time of the cancer.

  2. Recurrence-Free Survival

    Time frame: Every visit 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

    Recurrence-Free Survival is defined as the recurring time of the cancer or death.

  3. Overall Survival

    Time frame: Every visit 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

    Overall Survival is defined as the time of death from administraion of investigational product.

Sponsors and collaborators

Lead sponsor

GC Cell Corporation

Industry

Registry information

Official study title

Increased Dose, Repeated Injection Clinical to Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation With Hepatocellular Carcinoma Exceeding the Milan Criteria

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jun 12, 2019
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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