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出境医 / 临床实验 / Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation

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

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Liver Transplantation Biological: Immuncell-LC Phase 1 Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Liver cancer patients undergoing liver transplantation with hepatocellular carcinoma exceeding the Milan criteria
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : December 23, 2021
Estimated Study Completion Date : March 23, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Immuncell-LC group
Adjuvant adoptive immune therapy using a CIK cell agent(Cytokine-Induced Killer cells; Immuncell-LC) 3 times(3 treatments at a frequency of once per week) or 6 times(3 treatments at a frequency of once per week followed by 3 treatments every 2 weeks)
 Biological: Immuncell-LC
Activated T lymphocyte
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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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 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.
Contacts and Locations

Contacts
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Contact: Kyung Suk Suh, MD 82-2-2072-3789 kssuh@snu.ac.kr

Locations
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Korea, Republic of
Seoul National Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Kyung Suk Suh, MD    82-2-20723789    kssuh@snu.ac.kr   
Principal Investigator: Kyung Suk Suh, MD         
Sponsors and Collaborators
Green Cross Cell Corporation
Investigators
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Principal Investigator: Kyung Suk Suh, MD Seoul National University Hospital
Tracking Information
First Submitted Date  ICMJE March 12, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE January 24, 2019
Estimated Primary Completion Date December 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Liver cancer patients undergoing liver transplantation with hepatocellular carcinoma exceeding the Milan criteria
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Transplantation
Intervention  ICMJE Biological: Immuncell-LC
Activated T lymphocyte
Study Arms  ICMJE Experimental: Immuncell-LC group
Adjuvant adoptive immune therapy using a CIK cell agent(Cytokine-Induced Killer cells; Immuncell-LC) 3 times(3 treatments at a frequency of once per week) or 6 times(3 treatments at a frequency of once per week followed by 3 treatments every 2 weeks)
Intervention: Biological: Immuncell-LC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2019) 		18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 23, 2023
Estimated Primary Completion Date December 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kyung Suk Suh, MD 82-2-2072-3789 kssuh@snu.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983967
Other Study ID Numbers  ICMJE ILC-IIT-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Green Cross Cell Corporation
Study Sponsor  ICMJE Green Cross Cell Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyung Suk Suh, MD Seoul National University Hospital
PRS Account Green Cross Cell Corporation
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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