Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy
NCT ID: NCT03592706
Last Updated: 2020-04-16
Study Results
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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UNKNOWN
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2009-12-31
2021-08-31
Brief Summary
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1. Reduction of tumor size
2. Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IKC and TACE
IKC (Immune Killer Cells) and TACE(Transcatheter Arterial Chemoembolization)
IKC (Immune Killer Cells)
TACE (Transcatheter Arterial Chemoembolization)
TACE
TACE (Transcatheter Arterial Chemoembolization)
TACE (Transcatheter Arterial Chemoembolization)
Interventions
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IKC (Immune Killer Cells)
TACE (Transcatheter Arterial Chemoembolization)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
79 Years
ALL
No
Sponsors
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Tri-Service General Hospital
OTHER
Ivy Life Sciences, Co., Ltd
INDUSTRY
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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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