Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced HCC

June 22, 2023 updated by: GC Cell Corporation

Randomized, Open-label and Multi-center Clinical Trial to Evaluate the Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced Hepatocellular Carcinoma

"Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Nexavar to advanced Hepatocellular carcinoma patients when compared with the control group who did not receive administration of the drug.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • primary outcome Compare clinical efficacy of group treated with cell therapeutic Immuncell-LC evaluated by progression free survival with that of untreated group
  • secondary outcome compare clinical efficacy of group treated with Immuncell-LC, a drug for treating advanced hepatocellular carcinoma evaluated by overall survival, disease control rate, changes of Alpha Feto Protein(AFP) figures from baseline to the last observation date and that of untreated group and evaluate adverse reactions, clinical pathological tests and its safety.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of, 400-711
        • Inha University Hospital
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University Health System
      • Seoul, Korea, Republic of, 136-750
        • Korea University Anam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who have consented to the study by providing signature of self, guardian or legal representative
  • The patient is more than 20 and less than 80 years old
  • The patient is diagnosed as hepatocellular carcinoma by pathological/radiological test and in the stage of III or IV
  • Child-Pugh Score should be A
  • ECOG Performance Status (ECOG-PS) is less than 2 or equal to
  • Patients who receiving or ready for Nexavar treatment

  • Patients who satisfy the following conditions of the blood test and kidney function test

    • Absolute granulocyte count is bigger than 1,000/µL
    • Hemoglobin is bigger than 8.5 g/dL
    • Platelet count is bigger than 5x10^10/L
    • Blood Urea Nitrogen(BUN) or Creatinine 1.5xupper normal limit

Exclusion Criteria:

  • Patients who are immune deficient or have a history of auto-immune diseases (Ex. Rheumatoid Arthritism, 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 with the exception of basal cell carcinoma, local prostate cancer, and cervical cancer, liver cancer.
  • Patients who had anti-cancer medication before the study with the exception of Nexavar
  • Patients who has serious dysfunction in other organs by sub-investigator's opinion
  • Patients has serious allergic-history by sub-investigator's opinion
  • Patients has serious mental disease sub-investigator's opinion
  • Pregnant women, nursing mother of having intention of being pregnant during the study
  • Patients who participated in other clinical trial within 4 weeks before this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
The study subjects randomly assigned to the control group is given Nexavar chemotherapy according to the clinical test plans.
Experimental: Immuncell-LC group
The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after baseline by administering Nexavar chemotherapy same as control group with Immuncell-LC (10 times).
Drug: Immuncell-LC
intravenous dripping of 200ml(10^9~2x10^10 lymphocytes/60kg adult) for 1 hour
Other Names:
  • Activated T lymphocyte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess progression-free survival (PFS)
Time Frame: up to 2 years
CT, PET-CT, MRI
up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: up to 2 years
up to 2 years
To assess the overall survival (OS)
Time Frame: up to 2 years
up to 2 years
To evaluate the Disease control rate
Time Frame: up to 2 years
to determine response rate (CR, PR, SD rate) from the baseline to the late observation date using mRECIST
up to 2 years
To assess the changes of Alpha Feto Protein(AFP)figures from baseline to the last observation date
Time Frame: up to 2 years
analysing the changes of AFP before and after combination Nexavar plus Immuncell-LC
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GC Cell Corporation

Investigators

  • Principal Investigator: Soon Ho Um, MD, PhD, Korea University Anam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 4, 2017

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimated)

July 12, 2013

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILC-IIT-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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