HepatoCellular CarcinomaPhase 2/3NCT03592706
Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy
A Phase 2/3 study testing IKC (Immune Killer Cells) and TACE (Transcatheter Arterial Chemoembolization) in people with HepatoCellular Carcinoma and Liver Cancer, run by Ivy Life Sciences, Co., Ltd at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- HepatoCellular Carcinoma, Liver Cancer
- What is being tested?
- IKC (Immune Killer Cells) and TACE (Transcatheter Arterial Chemoembolization)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2009to Aug 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri Service General Hospital
Taipei
Chung-Bao Hsieh, MD, 02-87923311 ext. 17245, albert0920@yahoo.com.tw
Chung-Bao Hsieh, MD
About this study
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
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.
Read the 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.
- Conditions
- HepatoCellular Carcinoma, Liver Cancer
- Being tested
- IKC (Immune Killer Cells), TACE (Transcatheter Arterial Chemoembolization)
- Keywords
- HepatoCellular Carcinoma, Liver Cancer, Immune Killer Cells, IKC, Immune Therapy, Immunotherapy, Cell Therapy, IVY, IVY02
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IKC (Immune Killer Cells)Biological
Also called Autologous Immune Killer Cells
TACE (Transcatheter Arterial Chemoembolization)Procedure or surgery
Also called TACE
| Study group | Role | What they receive |
|---|---|---|
| IKC and TACE | Experimental | IKC (Immune Killer Cells) and TACE(Transcatheter Arterial Chemoembolization) Receives: Biological: IKC (Immune Killer Cells); Procedure: TACE (Transcatheter Arterial Chemoembolization) |
| TACE | Active comparator | TACE (Transcatheter Arterial Chemoembolization) Receives: Procedure: TACE (Transcatheter Arterial Chemoembolization) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
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
Measured: One year
Secondary outcomes (1)
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study startDec 2009
- Primary completionFeb 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatoCellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ivy Life Sciences, Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor
- Investigators
- Chung-Bao Hsieh, MD, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592706
- Sponsor's protocol ID
- IVY02
- Status last verified
- Apr 2020
- First submitted
- 5 Jul 2018
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03592706
- Acronym / sponsor ID
- IVY02
- Conditions
- HepatoCellular Carcinoma, Liver Cancer
- Keywords
- HepatoCellular Carcinoma, Liver Cancer, Immune Killer Cells, IKC, Immune Therapy, Immunotherapy, Cell Therapy, IVY
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ivy Life Sciences, Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Tri-Service General Hospital (TSGH)
- Study start
- Dec 2009 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IKC and TACE | Experimental | Biological: IKC (Immune Killer Cells), Procedure: TACE (Transcatheter Arterial Chemoembolization)IKC (Immune Killer Cells) and TACE(Transcatheter Arterial Chemoembolization) |
| TACE | Active comparator | Procedure: TACE (Transcatheter Arterial Chemoembolization)TACE (Transcatheter Arterial Chemoembolization) |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IKC (Immune Killer Cells)Also: Autologous Immune Killer Cells | Biological | IKC and TACE |
| TACE (Transcatheter Arterial Chemoembolization)Also: TACE | Procedure or surgery | IKC and TACE, TACE |
Primary outcome
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
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
1 secondary outcome
Improvement of immune responses
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung-Bao Hsieh, MD principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IKC (Immune Killer Cells) and TACE (Transcatheter Arterial Chemoembolization) in people with HepatoCellular Carcinoma and Liver Cancer, run by Ivy Life Sciences, Co., Ltd at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Executive Assistant ((02)8981-3333 ext. 114, thesteve@ivy-cd56.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of tumor size (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.