Hepatocellular CarcinomaPhase 2NCT02487017
DC-CIK Combined With TACE in the Treatment of Hepatocellular Carcinoma
A Phase 2 study testing Transcatheter Arterial Chemoembolization (TACE) and DC-CIK in people with Hepatocellular Carcinoma and Neoplasms, run by Shenzhen Hornetcorn Bio-technology Company, LTD at 1 site in China.
Trial summary
Evaluation of DC-CIK cells combined TACE treatment for HCC Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, Neoplasms, Digestive System Neoplasms
- What is being tested?
- Transcatheter Arterial Chemoembolization (TACE) and DC-CIK
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Dec 2018
- 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
- 18-80 years old;
- Histologically confirmed with Hepatocellular Carcinoma at stage I-II;
- Patients who can accept Transcatheter Arterial Chemoembolization ;
- Patients who have a life expectancy of at least 3 months;
- Patients who have a Child-Pugh:A/B; .Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.
Who cannot join
- White blood cell <3 x 10^9/L,Platelet count <75 x 10^9/L;BUN and Cr more than normal limits on 3.0 times ;
- Known or suspected allergy to the investigational agent or any agent given in association with this trial;
- Pregnant or lactating patients;
- Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
- Patients who are suffering from serious autoimmune disease;
- Patients who had used long time or are using immunosuppressant;
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- Patients who had active infection;
- Prior use of any anti-cancer treatment in 30 days;
- Now or recently will join another experimental clinical study ;
- History of organ allograft;
- Other situations that the researchers considered unsuitable for this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yantai City Hospital for Infectious Diseases
Yantai, Shandong, 264000
Xiangzhong Liu, Professor, 0535-6606193
About this study
Official title: Phase 2 Study of DC-CIK Cells Combined With TACE in the Treatment of Hepatocellular Carcinoma
Evaluation of DC-CIK cells combined TACE treatment for HCC
Read the detailed description
60 patients with Hepatocellular Carcinoma, who had received Transcatheter Arterial Chemoembolization (TACE) , will be randomly divided into group A (receive DC-CIK+ TACE treatment) or group B (just receive TACE), and the randomize ratio will be 1:1.
- Being tested
- Transcatheter Arterial Chemoembolization (TACE), DC-CIK
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasms, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Arterial Chemoembolization (TACE)Procedure or surgery
Transcatheter Arterial Chemoembolization (TACE):
5-FU 400mg/m2 Hepatic arterial infusion ,lipiodol amount is usually 20 ml,the perfusion time should not be less than 20 min
DC-CIKBiological
Transcatheter Arterial Chemoembolization (TACE):
5-FU 400mg/m2 Hepatic arterial infusion ,lipiodol amount is usually 20 ml, the perfusion time should not be less than 20 min
DC-CIK:
8×10^9 DC-CIK cells for each infusion, IV (in the vein) for each infusion at least 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Arterial Chemoembolization | Sham comparator | Transcatheter Arterial Chemoembolization treatment according to NCCN guidelines，patients will receive 5-FU Hepatic arterial infusion,3 cycles at least. Receives: Procedure: Transcatheter Arterial Chemoembolization (TACE) |
| DC-CIK | Experimental | After accepting concurrent TACE according to NCCN guidelines,patients will receive 3 cycles of DC-CIK treatment at least. Receives: Biological: DC-CIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 3 years
Secondary outcomes (3)
Progress-free survival
Measured: 3 years
Quality of life (QOL)
Measured: 3 years
Phenotypic analysis of T cells
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yantai City Hospital for Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- Xiangzhong Liu, Professor, Principal investigator, Yantai City Hospital for Infectious Diseases Immunotherapy center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487017
- Sponsor's protocol ID
- HYK-Hepatocellular Carcinoma
- Status last verified
- Dec 2015
- First submitted
- 29 Jun 2015
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of DC-CIK Cells Combined With TACE in the Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02487017
- Acronym / sponsor ID
- HYK-Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTDIndustry (pharma, biotech, devices)
- Collaborators
- Yantai City Hospital for Infectious Diseases
- Study start
- May 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Jul 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.
Evaluation of DC-CIK cells combined TACE treatment for HCC
Detailed description
60 patients with Hepatocellular Carcinoma, who had received Transcatheter Arterial Chemoembolization (TACE) , will be randomly divided into group A (receive DC-CIK+ TACE treatment) or group B (just receive TACE), and the randomize ratio will be 1:1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Arterial Chemoembolization | Sham comparator | Procedure: Transcatheter Arterial Chemoembolization (TACE)Transcatheter Arterial Chemoembolization treatment according to NCCN guidelines，patients will receive 5-FU Hepatic arterial infusion,3 cycles at least. |
| DC-CIK | Experimental | Biological: DC-CIKAfter accepting concurrent TACE according to NCCN guidelines,patients will receive 3 cycles of DC-CIK treatment at least. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-80 years old;
- Histologically confirmed with Hepatocellular Carcinoma at stage I-II;
- Patients who can accept Transcatheter Arterial Chemoembolization ;
- Patients who have a life expectancy of at least 3 months;
- Patients who have a Child-Pugh:A/B; .Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.
Key exclusion criteria (11 listed)
- White blood cell <3 x 10^9/L,Platelet count <75 x 10^9/L;BUN and Cr more than normal limits on 3.0 times ;
- Known or suspected allergy to the investigational agent or any agent given in association with this trial;
- Pregnant or lactating patients;
- Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
- Patients who are suffering from serious autoimmune disease;
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 |
|---|---|---|
| Transcatheter Arterial Chemoembolization (TACE)Transcatheter Arterial Chemoembolization (TACE): 5-FU 400mg/m2 Hepatic arterial infusion ,lipiodol amount is usually 20 ml,the perfusion time should not be less than 20 min | Procedure or surgery | Transcatheter Arterial Chemoembolization |
| DC-CIKTranscatheter Arterial Chemoembolization (TACE): 5-FU 400mg/m2 Hepatic arterial infusion ,lipiodol amount is usually 20 ml, the perfusion time should not be less than 20 min DC-CIK: 8×10^9 DC-CIK cells for each infusion, IV (in the vein) for each infusion at least 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32 | Biological | DC-CIK |
Primary outcome
Overall survival
Time frame: 3 years
3 secondary outcomes
Progress-free survival
Time frame: 3 years
Quality of life (QOL)
Time frame: 3 years
Phenotypic analysis of T cells
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- 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.
Xiangzhong Liu, Professor principal investigator
Yantai City Hospital for Infectious Diseases Immunotherapy center
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 Transcatheter Arterial Chemoembolization (TACE) and DC-CIK in people with Hepatocellular Carcinoma and Neoplasms, run by Shenzhen Hornetcorn Bio-technology Company, LTD 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 5 inclusion and 11 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 24 May 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. Some participants in this study may receive a placebo. 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 Xiangzhong Liu, Professor (0535-6606236, xiangzhong8686@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years). 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 24 May 2016.