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

NCT ID: NCT03592706

Last Updated: 2020-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2021-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HepatoCellular Carcinoma Liver Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IKC and TACE

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

Group Type EXPERIMENTAL

IKC (Immune Killer Cells)

Intervention Type BIOLOGICAL

TACE (Transcatheter Arterial Chemoembolization)

Intervention Type PROCEDURE

TACE

TACE (Transcatheter Arterial Chemoembolization)

Group Type ACTIVE_COMPARATOR

TACE (Transcatheter Arterial Chemoembolization)

Intervention Type PROCEDURE

Interventions

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IKC (Immune Killer Cells)

Intervention Type BIOLOGICAL

TACE (Transcatheter Arterial Chemoembolization)

Intervention Type PROCEDURE

Other Intervention Names

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Autologous Immune Killer Cells TACE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role collaborator

Ivy Life Sciences, Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chung-Bao Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

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Tri Service General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Executive Assistant

Role: CONTACT

(02)8981-3333 ext. 114

Facility Contacts

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Chung-Bao Hsieh, MD

Role: primary

02-87923311 ext. 17245

Other Identifiers

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IVY02

Identifier Type: -

Identifier Source: org_study_id

NCT01024530

Identifier Type: -

Identifier Source: nct_alias

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