Clinical trial NCT03592706: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: HepatoCellular Carcinoma
Liver Cancer
Keywords: HepatoCellular Carcinoma
Liver Cancer
Immune Killer Cells
IKC
Immune Therapy
Immunotherapy
Cell Therapy
IVY
IVY02
Lead sponsor: Ivy Life Sciences, Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Tri-Service General Hospital
First posted: 2018-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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：

1. Reduction of tumor size
2. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of tumor size
timeFrame: One year
measure: Progression-Free Survival (PFS)
timeFrame: One year
Secondary outcomes:
measure: Improvement of immune responses
timeFrame: One year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri Service General Hospital
Study officials:
affiliation: Tri-Service General Hospital
name: Chung-Bao Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References: