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

Primary Purpose

HepatoCellular Carcinoma, Liver Cancer

Status

Unknown status

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

IKC (Immune Killer Cells)

TACE (Transcatheter Arterial Chemoembolization)

About this trial

This is an interventional treatment trial for HepatoCellular Carcinoma focused on measuring HepatoCellular Carcinoma, Liver Cancer, Immune Killer Cells, IKC, Immune Therapy, Immunotherapy, Cell Therapy, IVY, IVY02

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Participant of other clinical trial within the past 4 weeks of screening period.
Receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period.
Carriers of HIV or HTLV within the past 4 weeks of screening period.
With Active acute or chronic infection by (investigator's judgement).
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).
Women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.

Sites / Locations

Tri Service General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IKC and TACE

TACE

Arm Description

IKC (Immune Killer Cells) and TACE(Transcatheter Arterial Chemoembolization)

TACE (Transcatheter Arterial Chemoembolization)

Outcomes

Primary Outcome Measures

Change of tumor size

Evaluate the efficacy of autologous immune killer cells using Response Evaluation Criteria in Solid Tumors (RECIST) by recording net changes of tumor sizes

Progression-Free Survival (PFS)

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

Secondary Outcome Measures

Improvement of immune responses

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

Full Information

NCT ID

NCT03592706

First Posted

July 5, 2018

Last Updated

April 14, 2020

Sponsor

Ivy Life Sciences, Co., Ltd

Collaborators

Tri-Service General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03592706

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (Actual)

Primary Completion Date

February 2021 (Anticipated)

Study Completion Date

August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ivy Life Sciences, Co., Ltd

Collaborators

Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in： Reduction of tumor size Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HepatoCellular Carcinoma, Liver Cancer

Keywords

HepatoCellular Carcinoma, Liver Cancer, Immune Killer Cells, IKC, Immune Therapy, Immunotherapy, Cell Therapy, IVY, IVY02

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IKC and TACE

Arm Type

Experimental

Arm Description

IKC (Immune Killer Cells) and TACE(Transcatheter Arterial Chemoembolization)

Arm Title

TACE

Arm Type

Active Comparator

Arm Description

TACE (Transcatheter Arterial Chemoembolization)

Intervention Type

Biological

Intervention Name(s)

IKC (Immune Killer Cells)

Other Intervention Name(s)

Autologous Immune Killer Cells

Intervention Type

Procedure

Intervention Name(s)

TACE (Transcatheter Arterial Chemoembolization)

Other Intervention Name(s)

TACE

Primary Outcome Measure Information:

Title

Change of tumor size

Description

Evaluate the efficacy of autologous immune killer cells using Response Evaluation Criteria in Solid Tumors (RECIST) by recording net changes of tumor sizes

Time Frame

One year

Title

Progression-Free Survival (PFS)

Description

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

Time Frame

One year

Secondary Outcome Measure Information:

Title

Improvement of immune responses

Description

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

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Sign and give written informed consent. Age≧20 years, but<80 years. Hepatocellular carcinoma by CT, MRI, AFP, angiography or cytology/biopsy examinations. Barcelona staging system stage B and C. Never receive TACE treatment and comply with the standard of TACE treatment. Child-Pugh stage A and B. ECOG performance status 0 to 2. Exclusion Criteria: Participant of other clinical trial within the past 4 weeks of screening period. Receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period. Carriers of HIV or HTLV within the past 4 weeks of screening period. With Active acute or chronic infection by (investigator's judgement). 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). Women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Executive Assistant

Phone

(02)8981-3333

Ext

114

thesteve@ivy-cd56.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chung-Bao Hsieh, MD

Organizational Affiliation

Tri-Service General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tri Service General Hospital

City

Taipei

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chung-Bao Hsieh, MD

Phone

02-87923311

Ext

17245

albert0920@yahoo.com.tw

First Name & Middle Initial & Last Name & Degree

Chung-Bao Hsieh, MD

12. IPD Sharing Statement

Learn more about this trial

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

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