Primary Hepatocellular CarcinomaDC-TCNCT01828762
Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
A study testing DC-TC+GM-CSF in people with Primary Hepatocellular Carcinoma, run by Shanghai AbelZeta Ltd. at 1 site in China.
Trial summary
Although liver resection, liver transplantation, a-interferon, Transarterial Chemo Embolization (TACE), percutaneous ethanol injection (PEI), Percutaneous microwave coagulation therapy (PMCT), Radiofrequency ablation (RFA) provide options to treat patients with HCC, the high recurrence rate of mid-late stage liver… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Hepatocellular Carcinoma
- What is being tested?
- DC-TC+GM-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 2013
- Phase
- Interventional
- 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
- Voluntary written informed consent signed by patient or legal guardian, obtained prior to study enrollment.
- BCLC Classification A-B
- Patients who are good surgical candidates for HCC resection
- ECOG Performance Score, 0-1
- Child-Pugh Rating, A
- Expected survival greater than 6 months
Who cannot join
- History of anaphylactic reaction to GM-CSF
- Congestive heart failure, unstable angina or other underlying cardiac disease; history of thrombosis currently requiring anticoagulation
- Mental or psychological illness preventing cooperation with treatment, efficacy evaluations, or unable to understand the informed consent process
- Primary cancers of any kind or location, other than hepatocellular carcinoma
- Excluding hepatitis, any active or unresolved infection including HIV, EBV, CMV, RPR, TB, etc.
- Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy.
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- Prior clinical trial requiring patient to receive an investigational drug within two weeks of enrollment.
- Pregnant or lactating women.
- Patients with the intention to receive transplantation
- Significant comorbidity or other active medical condition that could be eminently life threatening in the opinion of the investigator, including no active blood clotting or bleeding diathesis.
- Evidence of metastatic disease.
Trial locations and contacts
1 site in 1 country.
China1 site
9585 Humin Road,Xuhui district
Shanghai, Shanghai Municipality, 200235
About this study
Official title: Clinical Study of the Safety of Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
Although liver resection, liver transplantation, a-interferon, Transarterial Chemo Embolization (TACE), percutaneous ethanol injection (PEI), Percutaneous microwave coagulation therapy (PMCT), Radiofrequency ablation (RFA) provide options to treat patients with HCC, the high recurrence rate of mid-late stage liver cancer still exists. The safety of autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma (HCC) Patients Following Resection and TACE Therapy will be evaluated.
Read the detailed description
The study is a single center,open label trial. To obtain safety information on toxicities and adverse events attributable to the subcutaneous injections of autologous dendritic cells incubated with irradiated autologous tumor stem cells and suspended in GM-CSF in patients with HCC.
- Conditions
- Primary Hepatocellular Carcinoma
- Being tested
- DC-TC+GM-CSF
- Keywords
- DC, Immunotherapy, TC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC-TC+GM-CSFBiological
| Study group | Role | What they receive |
|---|---|---|
| DC-TC+GM-CSF | Experimental | Not described Receives: Biological: DC-TC+GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs，physical examinations and adverse events
The number of adverse events along with the results of vital signs measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of DC-TC.
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 posted11 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai AbelZeta Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- No.85 Hospital, Changning, Shanghai, China, China Cell Technology Ltd.
- Responsible party
- Sponsor
- Investigators
- Chengwei Chen, Principal investigator, No.85 Hospital, Changning, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828762
- Sponsor's protocol ID
- 040420100005
- Acronym
- DC-TC
- Status last verified
- Apr 2013
- First submitted
- 2 Apr 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Safety of Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
- ClinicalTrials.gov ID
- NCT01828762
- Acronym / sponsor ID
- DC-TC / 040420100005
- Conditions
- Primary Hepatocellular Carcinoma
- Keywords
- DC, Immunotherapy, TC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Shanghai AbelZeta Ltd.Industry (pharma, biotech, devices)
- Collaborators
- No.85 Hospital, Changning, Shanghai, China, China Cell Technology Ltd.
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- First posted
- 11 Apr 2013 (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.
Although liver resection, liver transplantation, a-interferon, Transarterial Chemo Embolization (TACE), percutaneous ethanol injection (PEI), Percutaneous microwave coagulation therapy (PMCT), Radiofrequency ablation (RFA) provide options to treat patients with HCC, the high recurrence rate of mid-late stage liver cancer still exists. The safety of autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma (HCC) Patients Following Resection and TACE Therapy will be evaluated.
Detailed description
The study is a single center,open label trial. To obtain safety information on toxicities and adverse events attributable to the subcutaneous injections of autologous dendritic cells incubated with irradiated autologous tumor stem cells and suspended in GM-CSF in patients with HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC-TC+GM-CSF | Experimental | Biological: DC-TC+GM-CSF |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary written informed consent signed by patient or legal guardian, obtained prior to study enrollment.
- BCLC Classification A-B
- Patients who are good surgical candidates for HCC resection
- ECOG Performance Score, 0-1
- Child-Pugh Rating, A
Key exclusion criteria (11 listed)
- History of anaphylactic reaction to GM-CSF
- Congestive heart failure, unstable angina or other underlying cardiac disease; history of thrombosis currently requiring anticoagulation
- Mental or psychological illness preventing cooperation with treatment, efficacy evaluations, or unable to understand the informed consent process
- Primary cancers of any kind or location, other than hepatocellular carcinoma
- Excluding hepatitis, any active or unresolved infection including HIV, EBV, CMV, RPR, TB, 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 |
|---|---|---|
| DC-TC+GM-CSF | Biological | DC-TC+GM-CSF |
Primary outcome
Vital signs，physical examinations and adverse events
Time frame: one year
The number of adverse events along with the results of vital signs measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of DC-TC.
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 23 Dec 2013.
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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.
Chengwei Chen principal investigator
No.85 Hospital, Changning, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DC-TC+GM-CSF in people with Primary Hepatocellular Carcinoma, run by Shanghai AbelZeta 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 6 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: finished, as of the sponsor's last update on 23 Dec 2013. 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.
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?
Vital signs，physical examinations and adverse events (time frame: one year). 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 23 Dec 2013.