Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy

April 14, 2020 updated by: Ivy Life Sciences, Co., Ltd

A Phase II/III Clinical Trial With Ex Vivo Expanded Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy

The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in：

  1. Reduction of tumor size
  2. Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a phase II/III clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of twelve infusions.

60 patients are anticipated to be recruited. This is a double-arm study, the experimental group will receive IKC treatment along with TACE treatment. The control group will receive only TACE treatment. 30 patients will be randomized into each arm.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

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

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Tri Service General Hospital
        • Contact:
        • Principal Investigator:
          • Chung-Bao Hsieh, MD

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 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Sign and give written informed consent.
  2. Age≧20 years, but<80 years.
  3. Hepatocellular carcinoma by CT, MRI, AFP, angiography or cytology/biopsy examinations.
  4. Barcelona staging system stage B and C.
  5. Never receive TACE treatment and comply with the standard of TACE treatment.
  6. Child-Pugh stage A and B.
  7. ECOG performance status 0 to 2.

Exclusion Criteria:

  1. Participant of other clinical trial within the past 4 weeks of screening period.
  2. Receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period.
  3. Carriers of HIV or HTLV within the past 4 weeks of screening period.
  4. With Active acute or chronic infection by (investigator's judgement).

  5. Other diseases, except hepatocellular carcinoma, which are life-threatening to the patients (by investigator's judgement) for example:

    5.1 Active cardiac disease requiring therapy for coronary artery disease, congestive heart failure, arrhythmia or myocardial infarction.

    5.2 With previous history of encephalopathy within the past six months.

    5.3 Involved Involving systemically or known central nerve system diseases(brain or meningeal metastasis).

  6. Women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.

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
Experimental: IKC and TACE
IKC (Immune Killer Cells) and TACE(Transcatheter Arterial Chemoembolization)
Biological: IKC (Immune Killer Cells)
Other Names:
  • Autologous Immune Killer Cells
Procedure: TACE (Transcatheter Arterial Chemoembolization)
Other Names:
  • TACE
Active Comparator: TACE
TACE (Transcatheter Arterial Chemoembolization)
Procedure: TACE (Transcatheter Arterial Chemoembolization)
Other Names:
  • TACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of tumor size
Time Frame: One year
Evaluate the efficacy of autologous immune killer cells using Response Evaluation Criteria in Solid Tumors (RECIST) by recording net changes of tumor sizes
One year
Progression-Free Survival (PFS)
Time Frame: One year
The length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of immune responses
Time Frame: One year
Evaluate the efficacy and safety of in vitro proliferating autoimmune killer cells as adjuvant therapy for the treatment of liver cancer patients and promote anti-cancer immune responses
One year

Collaborators and Investigators

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

Sponsor

Ivy Life Sciences, Co., Ltd

Collaborators

Tri-Service General Hospital

Investigators

  • Principal Investigator: Chung-Bao Hsieh, MD, Tri-Service General Hospital

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 (Actual)

December 1, 2009

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

July 18, 2018

First Posted (Actual)

July 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVY02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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