Hepatocellular CarcinomaPhase 2NCT02854839
A Study of MG4101 (Allogeneic Natural Killer Cell) for Intermediate-stage of Hepatocellular Carcinoma
A Phase 2 study testing MG4101 in people with Hepatocellular Carcinoma, run by GC Cell Corporation at 6 sites in South Korea.
Trial summary
The propose of this study is evaluate the safety and efficacy of MG4101 (allogeneic Natural killer cells) in patients with hepatocellular carcinoma (HCC) after transarterial chemoembolization (TACE). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- MG4101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 28 Nov 2016to 17 Sep 2019
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are between 20 to 80 years of age
- Life expectancy > 12 weeks
- Patients have complete remission according to the mRECIST by Dynamic contrast-enhanced 3- or 4-phase CT or tissue biopsy
- Patients were diagnosed Hepatocellular Carcinoma BCLC stage B be-fore TACE.
- Dynamic contrast-enhanced CT must be within 4 weeks after the TACE.
- Previous TACE with the following:
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- Lipiodol mixed with chemotherapy (such as adriamycin etc.)
- Used with Gelatin sponge or Polyvinyl alcohol or microsphere.
- Patients who had local treatment such as Resection, Radiofrequency Ablation, Percutaneous ethanol injection and Transarterial chemoembolization can participates study.
- Patients whose Child-Pugh score is less than B8.
- Patients whose ECOG score is 0
- Patients who satisfy the following conditions of the blood test, kidney function test, and liver function test.
- Absolute neutrophil count ≥ 1,000 x 10^6 /L
- hemoglobin level ≥ 8.5 g/㎗
- platelet count ≥ 50,000 /㎣
- Total bilirubin < 3.0 ㎎/㎗
- Serum creatinine ≤ 1.5 x upper normal limit (UNL)
- Total Albumin ≥ 2.8 ㎎/㎗
- Able and willing to provide written informed consent and to comply with the study protocol.
Who cannot join
- Patients who have metastasis.
- Patients who have Portal vein or hepatic vein invasion.
- Patient with medical history for the following:
- Patients with Living donor Liver Transplantation or Orthotopic liver transplantation.
- Patients who have received anti-cancer chemotherapy for 4 weeks prior to the study.
- Patients who have not recovered adverse reaction prior to the study.
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- Patients who have received external beam radiation on liver, immunotherapy, cell therapy, and target therapy.
- Prior use of systemic anticancer chemotherapy twice.
- Patients who have a history of malignant tumors in 5 years prior to the study with the exception of Carcinoma in situ..
- Patients who have a history of autoimmune disease such as Rheuma-toid arthritis, systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-dependent Diabetes Mellitus, etc.
- Patients who have history of human immunodeficiency virus (HIV) infection.
- Patients who have participated in other clinical trials within 4 weeks prior to this study.
- Patients who treated with immunosuppressant for 3 months prior to this study.
- Patients who have any condition that was uncontrolled or needed treatment.
- Pregnant or breast-feeding subjects.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Seoul National University Hospital
Seoul, 03080
Seoul Asan Medical center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Korea Univ. Guro Hospital
Seoul
Severance hospital
Seoul
Ajou Univ. Hospital
Suwon
About this study
Official title: Multi-center, Open, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of MG4101 in Hepatocellular Carcinoma After TACE
The propose of this study is evaluate the safety and efficacy of MG4101 (allogeneic Natural killer cells) in patients with hepatocellular carcinoma (HCC) after transarterial chemoembolization (TACE).
Read the detailed description
This is randomized, multi-center, open-labeled, Phase 2a study in patients with HCC after transarterial chemoembolization (TACE). A total of 78 patients will be randomized(1:1) into one of the two group, to receive adjuvant therapy using MG4101 (allogeneic Natural killer cells, Treatment group) or no adjuvant therapy (Control group).
Patients who were assigned Treatment group will receive 2 cycles of MG4101 (each cycle is 3 treatments at a frequency of once per week, between each cycle has 3 weeks of withdrawal period). After treatment period, patients will undergo follow up for progression and survival every 12 weeks (± 7 days) and follow up 1 year after the last patient's enrollment date.
The Control group's patients will will undergo follow up for progression and survival every 12 weeks (± 7 days) and follow up 1 year after the last patient's enrollment date.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- MG4101
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MG4101Biological
Also called allogeneic natural killer cells
MG4101 is ex vivo-expanded, allogeneic natural killer cells. MG4101 were manufactured from normal healthy donor who underwent lymphopheresis under good manufacturing practice (GMP) conditions.
| Study group | Role | What they receive |
|---|---|---|
| The Control Group | No intervention | Patients will be randomized 1:1 to the control group and the treatment group. Patients who had allocated control group will not receive adjuvant treatment. |
| The Treatment Group (MG4101) | Experimental | Patients will be randomized 1:1 to the control group and the treatment group. The treatment group will receive 6 times of MG4101(allogeneic natural killer cells) on week 0, 1, 2, 5, 6, 7. Receives: Biological: MG4101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To progression
Measured: every 12 weeks, up to the time of death or 18 months
Secondary outcomes (4)
Progression-free survival
Measured: every 12 weeks, up to the time of death or tumor progression, up to 18 months
Overall survival
Measured: every 12 weeks, up to the time of death, up to 18 months
change of Tumor Markers(AFP, Alpha-Fetoprotein)
Measured: every 12 weeks, up to the time of death or tumor progression, up to 18 months
Safety of MG4101 as evaluated by Incidence of adverse events (AEs), serious adverse events (SAEs)
Measured: up tp 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start28 Nov 2016
- Primary completion27 Sep 2018
- Study completion17 Sep 2019
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- GC Cell Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jung Hwan Yoon, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854839
- Sponsor's protocol ID
- MG4101-HCC-P2a
- Status last verified
- Oct 2018
- First submitted
- 28 Jul 2016
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Open, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of MG4101 in Hepatocellular Carcinoma After TACE
- ClinicalTrials.gov ID
- NCT02854839
- Acronym / sponsor ID
- MG4101-HCC-P2a
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- GC Cell CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 4 Aug 2016 (estimated)
- 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 propose of this study is evaluate the safety and efficacy of MG4101 (allogeneic Natural killer cells) in patients with hepatocellular carcinoma (HCC) after transarterial chemoembolization (TACE).
Detailed description
This is randomized, multi-center, open-labeled, Phase 2a study in patients with HCC after transarterial chemoembolization (TACE). A total of 78 patients will be randomized(1:1) into one of the two group, to receive adjuvant therapy using MG4101 (allogeneic Natural killer cells, Treatment group) or no adjuvant therapy (Control group).
Patients who were assigned Treatment group will receive 2 cycles of MG4101 (each cycle is 3 treatments at a frequency of once per week, between each cycle has 3 weeks of withdrawal period). After treatment period, patients will undergo follow up for progression and survival every 12 weeks (± 7 days) and follow up 1 year after the last patient's enrollment date.
The Control group's patients will will undergo follow up for progression and survival every 12 weeks (± 7 days) and follow up 1 year after the last patient's enrollment date.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Control Group | No intervention | –Patients will be randomized 1:1 to the control group and the treatment group. Patients who had allocated control group will not receive adjuvant treatment. |
| The Treatment Group (MG4101) | Experimental | Biological: MG4101Patients will be randomized 1:1 to the control group and the treatment group. The treatment group will receive 6 times of MG4101(allogeneic natural killer cells) on week 0, 1, 2, 5, 6, 7. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients who are between 20 to 80 years of age
- Life expectancy > 12 weeks
- Patients have complete remission according to the mRECIST by Dynamic contrast-enhanced 3- or 4-phase CT or tissue biopsy
- Previous TACE with the following:
- Patients who had local treatment such as Resection, Radiofrequency Ablation, Percutaneous ethanol injection and Transarterial chemoembolization can participates study.
Key exclusion criteria (15 listed)
- Patients who have metastasis.
- Patients who have Portal vein or hepatic vein invasion.
- Patient with medical history for the following:
- Patients who have a history of malignant tumors in 5 years prior to the study with the exception of Carcinoma in situ..
- Patients who have a history of autoimmune disease such as Rheuma-toid arthritis, systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-dependent Diabetes Mellitus, etc.
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 |
|---|---|---|
| MG4101Also: allogeneic natural killer cellsMG4101 is ex vivo-expanded, allogeneic natural killer cells. MG4101 were manufactured from normal healthy donor who underwent lymphopheresis under good manufacturing practice (GMP) conditions. | Biological | The Treatment Group (MG4101) |
Primary outcome
Time To progression
Time frame: every 12 weeks, up to the time of death or 18 months
4 secondary outcomes
Progression-free survival
Time frame: every 12 weeks, up to the time of death or tumor progression, up to 18 months
Overall survival
Time frame: every 12 weeks, up to the time of death, up to 18 months
change of Tumor Markers(AFP, Alpha-Fetoprotein)
Time frame: every 12 weeks, up to the time of death or tumor progression, up to 18 months
Safety of MG4101 as evaluated by Incidence of adverse events (AEs), serious adverse events (SAEs)
Time frame: up tp 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Jung Hwan Yoon, M.D., Ph.D. principal investigator
Seoul National University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MG4101 in people with Hepatocellular Carcinoma, run by GC Cell Corporation at 6 sites in South Korea.
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 19 inclusion and 15 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: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time To progression (time frame: every 12 weeks, up to the time of death or 18 months). 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 26 Sep 2019.