Hepatocellular CarcinomaPhase 2NCT02725996
By Using Adoptive Transfer of Autologous NK Cells to Prevent Recurrence of Hepatocellular Carcinoma After Curative Therapy
A Phase 2 study testing NK cells and Curative therapy in people with Hepatocellular Carcinoma, run by Southwest Hospital, China at 1 site in China.
Trial summary
To prove that the efficacy and safety of 'NK group' is superior to 'non-treatment group(Control group)' in patient undergone curative resection(RFA or operation) for hepatocellular carcinoma in China. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- NK cells and Curative therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Apr 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior to the test, patient is fully explained about the purpose/ contents and characteristics of the testing medication, and the patient him(her)self, the guardian or the legal representative signed on written consent.
- Gender unlimited, age from 18 years to 70 years
- The patient is diagnosed as hepatocellular carcinoma by pathological/ radiological test and he (she) is in the stage of I or II. (refer to the attached file 10). Hepatocellular carcinoma should be shown by radiological test; on dynamic CT, dynamic MRI or on angiography.
- Child-Pugh Score should be less than 6
- No matter how the patient has been treated before, his (her) tumor should be totally removed by curative resection (RFA or operation). (based on the agreement date for written consent)
- Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
- Patient's remaining life-time should be expected at least more than 3 months.
Who cannot join
- Hepatocellular carcinoma has been transferred by pathological/ radiological test (Stage III or Stage IV, refer to the exhibit 10)
- The carcinoma has been invaded to main portal vein or major branch hepatic vein
- Child-Pugh score is over 6
- Patient has serious problem with pulmonary function by sub- investigator's opinion
- Patient who has disease history of immune deficiency
- Diagnosed as an immune deficiency patient
Show all 13Show fewer
- Patient who has disease history of malignant tumor within 5 years before this clinical trial.
- Patient who had anti-cancer medication before the clinical trial
- Patient has serious allergic-history by sub- investigator's opinion
- Patient has serious mental disease by sub- investigator's opinion
- Pregnant women, nursing mother or having intention of being pregnant during the clinical test
- Patient who participated in other clinical trial within 4 weeks before this clinical trial
- Patient who is incongruent to this clinical trial by sub- investigator's opinion.
Trial locations and contacts
1 site in 1 country.
China1 site
Southwest Hospital of Third Millitary Medical University
Chongqing, Chongqing Municipality, 400000
Cheng Qian, PhD, 008615086883400, cqian3184@163.com
Zhi Yang, PhD, 008613206140093
About this study
To prove that the efficacy and safety of 'NK group' is superior to 'non-treatment group(Control group)' in patient undergone curative resection(RFA or operation) for hepatocellular carcinoma in China.
Read the detailed description
No adjuvant therapy has been shown to extend the survival of patients with hepatocellular carcinoma receiving curative treatment.We investigated whether injections of NK cells prolongs recurrence-free survival of patients after curative therapy.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- NK cells, Curative therapy
- Keywords
- Hepatocellular Carcinoma, Natural Killer cells
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK cellsBiological
Also called natural killer cell infusion
Adjuvant adoptive immune therapy using NK cell 4 times
Curative therapyOther
Patients who had undergone curative treatment(surgical resection or radiofrequency ablation for HCC of pretreatment clinical stage I or II were eligible for this study with no adjuvant treatment
| Study group | Role | What they receive |
|---|---|---|
| curative therapy+NK infusion | Experimental | Adjuvant adoptive immune therapy using NK cell 4 times after curative therapy Receives: Biological: NK cells; Other: Curative therapy |
| curative therapy | Other | Patients who had undergone curative treatment(surgical resection or radiofrequency ablation[RFA]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment Receives: Other: Curative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival(RFS) :RFS was measured from the date of randomization to the first recurrence or to death from any cause.
Measured: 3 years
Overall Survival(OS) :Overall survival was measured from the date of randomization until death from any cause.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2019 (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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi Yang, Southwest Hospital, China
- Investigators
- Cheng Qian, MD, PhD, Study chair, Biotherapy Center of Southwest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725996
- Sponsor's protocol ID
- TMMU-BTC-006
- Status last verified
- Mar 2016
- First submitted
- 28 Mar 2016
- Last updated
- 25 Apr 2017
- 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 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- By Using Adoptive Transfer of Autologous NK Cells to Prevent Recurrence of Hepatocellular Carcinoma After Curative Therapy
- ClinicalTrials.gov ID
- NCT02725996
- Acronym / sponsor ID
- TMMU-BTC-006
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Natural Killer cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 1 Apr 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.
To prove that the efficacy and safety of 'NK group' is superior to 'non-treatment group(Control group)' in patient undergone curative resection(RFA or operation) for hepatocellular carcinoma in China.
Detailed description
No adjuvant therapy has been shown to extend the survival of patients with hepatocellular carcinoma receiving curative treatment.We investigated whether injections of NK cells prolongs recurrence-free survival of patients after curative therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| curative therapy+NK infusion | Experimental | Biological: NK cells, Other: Curative therapyAdjuvant adoptive immune therapy using NK cell 4 times after curative therapy |
| curative therapy | Other | Other: Curative therapyPatients who had undergone curative treatment(surgical resection or radiofrequency ablation[RFA]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Prior to the test, patient is fully explained about the purpose/ contents and characteristics of the testing medication, and the patient him(her)self, the guardian or the legal representative signed on written consent.
- Gender unlimited, age from 18 years to 70 years
- The patient is diagnosed as hepatocellular carcinoma by pathological/ radiological test and he (she) is in the stage of I or II. (refer to the attached file 10). Hepatocellular carcinoma should be shown by radiological test; on dynamic CT, dynamic MRI or on angiography.
- Child-Pugh Score should be less than 6
- No matter how the patient has been treated before, his (her) tumor should be totally removed by curative resection (RFA or operation). (based on the agreement date for written consent)
Key exclusion criteria (13 listed)
- Hepatocellular carcinoma has been transferred by pathological/ radiological test (Stage III or Stage IV, refer to the exhibit 10)
- The carcinoma has been invaded to main portal vein or major branch hepatic vein
- Child-Pugh score is over 6
- Patient has serious problem with pulmonary function by sub- investigator's opinion
- Patient who has disease history of immune deficiency
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 |
|---|---|---|
| NK cellsAlso: natural killer cell infusionAdjuvant adoptive immune therapy using NK cell 4 times | Biological | curative therapy+NK infusion |
| Curative therapyPatients who had undergone curative treatment(surgical resection or radiofrequency ablation for HCC of pretreatment clinical stage I or II were eligible for this study with no adjuvant treatment | Other | curative therapy, curative therapy+NK infusion |
Primary outcome
Recurrence Free Survival(RFS) :RFS was measured from the date of randomization to the first recurrence or to death from any cause.
Time frame: 3 years
Overall Survival(OS) :Overall survival was measured from the date of randomization until death from any cause.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- 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.
Cheng Qian, MD, PhD study chair
Biotherapy Center of Southwest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NK cells and Curative therapy in people with Hepatocellular Carcinoma, run by Southwest Hospital, China 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 7 inclusion and 13 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 25 Apr 2017. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng Qian, MD, PhD (0086-023-68765461, cqian3184@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Free Survival(RFS) :RFS was measured from the date of randomization to the first recurrence or to death from any cause. (time frame: 3 years). 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 25 Apr 2017.