Hepatocellular CarcinomaPhase 1NCT02399735
Safety Study of NK Cells From Sibship to Treat the Recurrence of HCC After Liver Transplantation
A Phase 1 study testing Low Dose NK cells ×4 times, Normal Dose NK cells ×4 times and Normal Dose NK cells ×8 times in people with Hepatocellular Carcinoma, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to explore the safety of NK cells from Sibship in patients with recurrent hepatocellular carcinoma after liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Low Dose NK cells ×4 times, Normal Dose NK cells ×4 times and Normal Dose NK cells ×8 times
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Jun 2018
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proved hepatocellular carcinoma histologically after liver transplantation.
- Confirmed recurrence of hepatocellular carcinoma by CT/MRI.
- The same blood type relatives with blood transmitted diseases negative.
- Written informed consent.
Who cannot join
- Autoimmune diseases require long-term of glucocorticoid.
- Other candidates who are judged to be not applicable to this study by investigators.
- Poor compliance.
Trial locations and contacts
1 site in 1 country.
Wang Guoying, MD contact
China1 site, 1 recruiting
- Recruiting
Wang Guoying
Guangzhou, Guangdong, 510630
Wang Guoying, MD, 086-13632407313, wanggy3@126.com
About this study
Official title: Safety Study of Nature Killer Cells From Sibship to Treat the Recurrence of Hepatocellular Carcinoma After Liver Transplantation
The purpose of this study is to explore the safety of NK cells from Sibship in patients with recurrent hepatocellular carcinoma after liver transplantation.
Read the detailed description
Hepatocellular carcinoma (HCC) is one of the indications for the liver transplantation. With the advancement of liver transplantation associated science and technology, the recurrence of tumor posttransplantation has become the principal contradiction to worsen the prognosis and therefore the prevention of recurrence of HCC is the key to improve the efficacy of liver transplantation. Adoptive cellular immunotherapy has been applied in various malignant tumors including HCC and has obtained significant effects. But for patients with liver transplant in immunosuppressed states, to successfully apply the immune cells to prevent and treat HCC relapse after liver transplantation must balance immunosuppression and anti-tumor immunity. It is necessary to consider the safety of adoptive cellular immunotherapy,and it is also necessary to consider the effectiveness of treatment that the immune cells in the immunosuppression state can exert anti-tumor effects. Natural killer cells (NK cells) have MHC-unrestricted killing effect on malignant tumor cells and are not major mediating cells for GVHD, and might be an optimum choice to meet the above requirements.
Patients with confirmed recurrence of hepatocellular carcinoma after liver transplantation at the Third Affiliated Hospital of Sun Yat-sen University were enrolled.Participants in the study will be assigned to one of three treatment arms:
Arm A: Participants will received conventional treatment and low dose of NK cells treatment for 4 times. Arm B: Participants will received conventional treatment and normal dose of NK cells treatment for 4 times. Arm C: Participants will received conventional treatment and normal dose of NK cells treatment for 8 times. The cultured NK cells from the peripheral blood of the same blood type were taken and infused at intervals of two weeks. Periodic liver function recheck and imaging examination were conducted for 6 months after the last NK cells infusion.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Low Dose NK cells ×4 times, Normal Dose NK cells ×4 times, Normal Dose NK cells ×8 times
- Keywords
- NK cells, Liver Transplantation, Hepatocellular Carcinoma Recurrence
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose NK cells ×4 timesBiological
Also called low dose Natural killer cells ×4 times
Received conventional treatment and NK cells once per two-week for the first two-month, at a dose of 5×10E9 NK cells.
Normal Dose NK cells ×4 timesBiological
Also called normal dose Natural killer cells ×4 times
Received conventional treatment and NK cells once per two-week for the first two-month, at a dose of 1×10E10 NK cells.
Normal Dose NK cells ×8 timesBiological
Also called normal dose Natural killer cells ×8 times
Received conventional treatment and NK cells once per two-week for the first four-month, at a dose of 1×10E10 NK cells.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Received conventional treatment and NK cells once per two-week for the first two-month, at a dose of 5×10E9 NK cells. Receives: Biological: Low Dose NK cells ×4 times |
| Arm B | Experimental | Received conventional treatment and NK cells once per two-week for the first two-month, at a dose of 1×10E10 NK cells. Receives: Biological: Normal Dose NK cells ×4 times |
| Arm C | Experimental | Received conventional treatment and NK cells once per two-week for the first four-month, at a dose of 1×10E10 NK cells. Receives: Biological: Normal Dose NK cells ×8 times |
What is being measured
The primary outcome is the main question the study is designed to answer.
GVHD
Rash, fever, diarrhea, jaundice etc. leukocyte, platelet, red blood cells reduce, abnormal liver function.Pathological biopsy if necessary.
Measured: 6 months
Secondary outcomes (1)
Acute rejection
abnormal liver function，pathological biopsy if necessary.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Guoying, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yang Yang, MD, Study chair, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399735
- Sponsor's protocol ID
- (2014)2-126
- Status last verified
- Jun 2016
- First submitted
- 23 Mar 2015
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang F, Gong Y, Zheng X, Ni B, Lu J, Chen X, Cheng J, Li P, Du C, Chen Y, Zhang Y, Yi S, Wang G, Zhang Q, Yang Y, Chen W. NK cell infusion is well-tolerated and shows preliminary efficacy in patients with recurrent hepatocellular carcinoma post-liver transplantation : a phase I trial. J Transl Med. 2026 Jan 24;24(1):261. doi: 10.1186/s12967-026-07725-x.
PubMed 41580832
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Nature Killer Cells From Sibship to Treat the Recurrence of Hepatocellular Carcinoma After Liver Transplantation
- ClinicalTrials.gov ID
- NCT02399735
- Acronym / sponsor ID
- (2014)2-126
- Conditions
- Hepatocellular Carcinoma
- Keywords
- NK cells, Liver Transplantation, Hepatocellular Carcinoma Recurrence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 26 Mar 2015 (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 purpose of this study is to explore the safety of NK cells from Sibship in patients with recurrent hepatocellular carcinoma after liver transplantation.
Detailed description
Hepatocellular carcinoma (HCC) is one of the indications for the liver transplantation. With the advancement of liver transplantation associated science and technology, the recurrence of tumor posttransplantation has become the principal contradiction to worsen the prognosis and therefore the prevention of recurrence of HCC is the key to improve the efficacy of liver transplantation. Adoptive cellular immunotherapy has been applied in various malignant tumors including HCC and has obtained significant effects. But for patients with liver transplant in immunosuppressed states, to successfully apply the immune cells to prevent and treat HCC relapse after liver transplantation must balance immunosuppression and anti-tumor immunity. It is necessary to consider the safety of adoptive cellular immunotherapy,and it is also necessary to consider the effectiveness of treatment that the immune cells in the immunosuppression state can exert anti-tumor effects. Natural killer cells (NK cells) have MHC-unrestricted killing effect on malignant tumor cells and are not major mediating cells for GVHD, and might be an optimum choice to meet the above requirements.
Patients with confirmed recurrence of hepatocellular carcinoma after liver transplantation at the Third Affiliated Hospital of Sun Yat-sen University were enrolled.Participants in the study will be assigned to one of three treatment arms:
Arm A: Participants will received conventional treatment and low dose of NK cells treatment for 4 times. Arm B: Participants will received conventional treatment and normal dose of NK cells treatment for 4 times. Arm C: Participants will received conventional treatment and normal dose of NK cells treatment for 8 times. The cultured NK cells from the peripheral blood of the same blood type were taken and infused at intervals of two weeks. Periodic liver function recheck and imaging examination were conducted for 6 months after the last NK cells infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: Low Dose NK cells ×4 timesReceived conventional treatment and NK cells once per two-week for the first two-month, at a dose of 5×10E9 NK cells. |
| Arm B | Experimental | Biological: Normal Dose NK cells ×4 timesReceived conventional treatment and NK cells once per two-week for the first two-month, at a dose of 1×10E10 NK cells. |
| Arm C | Experimental | Biological: Normal Dose NK cells ×8 timesReceived conventional treatment and NK cells once per two-week for the first four-month, at a dose of 1×10E10 NK cells. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Proved hepatocellular carcinoma histologically after liver transplantation.
- Confirmed recurrence of hepatocellular carcinoma by CT/MRI.
- The same blood type relatives with blood transmitted diseases negative.
- Written informed consent.
Key exclusion criteria (3 listed)
- Autoimmune diseases require long-term of glucocorticoid.
- Other candidates who are judged to be not applicable to this study by investigators.
- Poor compliance.
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 |
|---|---|---|
| Low Dose NK cells ×4 timesAlso: low dose Natural killer cells ×4 timesReceived conventional treatment and NK cells once per two-week for the first two-month, at a dose of 5×10E9 NK cells. | Biological | Arm A |
| Normal Dose NK cells ×4 timesAlso: normal dose Natural killer cells ×4 timesReceived conventional treatment and NK cells once per two-week for the first two-month, at a dose of 1×10E10 NK cells. | Biological | Arm B |
| Normal Dose NK cells ×8 timesAlso: normal dose Natural killer cells ×8 timesReceived conventional treatment and NK cells once per two-week for the first four-month, at a dose of 1×10E10 NK cells. | Biological | Arm C |
Primary outcome
GVHD
Time frame: 6 months
Rash, fever, diarrhea, jaundice etc. leukocyte, platelet, red blood cells reduce, abnormal liver function.Pathological biopsy if necessary.
1 secondary outcome
Acute rejection
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- Derived from this study: PubMed 41580832Yang F, Gong Y, Zheng X, Ni B, Lu J, Chen X, Cheng J, Li P, Du C, Chen Y, Zhang Y, Yi S, Wang G, Zhang Q, Yang Y, Chen W. NK cell infusion is well-tolerated and shows preliminary efficacy in patients with recurrent hepatocellular carcinoma post-liver transplantation : a phase I trial. J Transl Med. 2026 Jan 24;24(1):261. doi: 10.1186/s12967-026-07725-x.
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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.
Wang Guoying, MD contact
Yang Yang, MD study chair
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low Dose NK cells ×4 times, Normal Dose NK cells ×4 times and Normal Dose NK cells ×8 times in people with Hepatocellular Carcinoma, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 4 inclusion and 3 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 21 Jul 2016. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Wang Guoying, MD (086-13632407313, wanggy3@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GVHD (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02399735, which also lists 1 linked publication.
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 21 Jul 2016.