Esophagus CancerPhase 1/2NCT02693236
DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer
A Phase 1/2 study testing adenovirus-transfected autologous DC vaccine plus CIK cells in people with Esophagus Cancer, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) combined with cytokine-induced killer (CIK) cells in patients with advanced esophagus cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- adenovirus-transfected autologous DC vaccine plus CIK cells
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Nov 2016
- Phase
- Phase 1/2
- 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
- Histopathologically confirmed diagnosis of esophagus cancer
- Age >18 years at time of consent
- Received standardized treatment of Small-Cell Lung Cancer
- Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
- KPS (Karnofsky performance scale) >60
- Patient's written informed consent
- No severe viral or bacterial infections
- Predicted survival >3 months
Who cannot join
- Serious dysfunction of vital organs(heart, liver or kidney)
- History of autoimmune diseases
- Pregnant and breast-feeding patient
- Active or chronic infectious diseases
- History of allergy or hypersensitivity to study product excipients
- Currently participating in another clinical trial
- Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks
- Clinically relevant diseases or infections (HBV, HCV, HIV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Research of Genetically Modified Dendritic Cells in Combination With Cytokine-induced Killer Cell Treatment in Middle and Advanced Esophagus Cancer Patients
The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) combined with cytokine-induced killer (CIK) cells in patients with advanced esophagus cancer. Experimental recombinant adenovirus coded mRNA including MUC1 and Survivin that transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the researcher plan to perform the clinical trial.
- Conditions
- Esophagus Cancer
- Being tested
- adenovirus-transfected autologous DC vaccine plus CIK cells
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adenovirus-transfected autologous DC vaccine plus CIK cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| adenovirus-transfected autologous DC vaccine plus CIK cells | Experimental | Not described Receives: Biological: adenovirus-transfected autologous DC vaccine plus CIK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective rate response (CR+PR) as measured by RECIST criteria
Measured: Time Frame: 4 weeks after DC/CIK treatment
Secondary outcomes (1)
number of participants with adverse events
Measured: Time Frame: 3 days within DC/CIK treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startAug 2014
- Primary completionAug 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693236
- Sponsor's protocol ID
- 307-CTC-DC/CIK-EC
- Status last verified
- Oct 2015
- First submitted
- 23 Feb 2016
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of Genetically Modified Dendritic Cells in Combination With Cytokine-induced Killer Cell Treatment in Middle and Advanced Esophagus Cancer Patients
- ClinicalTrials.gov ID
- NCT02693236
- Acronym / sponsor ID
- 307-CTC-DC/CIK-EC
- Conditions
- Esophagus Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 26 Feb 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 aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) combined with cytokine-induced killer (CIK) cells in patients with advanced esophagus cancer. Experimental recombinant adenovirus coded mRNA including MUC1 and Survivin that transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the researcher plan to perform the clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adenovirus-transfected autologous DC vaccine plus CIK cells | Experimental | Biological: adenovirus-transfected autologous DC vaccine plus CIK cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histopathologically confirmed diagnosis of esophagus cancer
- Age >18 years at time of consent
- Received standardized treatment of Small-Cell Lung Cancer
- Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
- KPS (Karnofsky performance scale) >60
Key exclusion criteria (8 listed)
- Serious dysfunction of vital organs(heart, liver or kidney)
- History of autoimmune diseases
- Pregnant and breast-feeding patient
- Active or chronic infectious diseases
- History of allergy or hypersensitivity to study product excipients
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 |
|---|---|---|
| adenovirus-transfected autologous DC vaccine plus CIK cells | Biological | adenovirus-transfected autologous DC vaccine plus CIK cells |
Primary outcome
objective rate response (CR+PR) as measured by RECIST criteria
Time frame: Time Frame: 4 weeks after DC/CIK treatment
1 secondary outcome
number of participants with adverse events
Time frame: Time Frame: 3 days within DC/CIK treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing adenovirus-transfected autologous DC vaccine plus CIK cells in people with Esophagus Cancer, run by Affiliated Hospital to Academy of Military Medical Sciences 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 8 inclusion and 8 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 26 Feb 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 combined 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.
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?
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?
objective rate response (CR+PR) as measured by RECIST criteria (time frame: Time Frame: 4 weeks after DC/CIK treatment). 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 Feb 2016.