Esophageal NeoplasmsPhase 2NCT02644863
Autologous Tumor Tissue Antigen-sensitized DC-CIK Cells Combined With Chemotherapy for Esophageal Cancer
A Phase 2 study testing Paclitaxel, DC-CIK and Cisplatin in people with Esophageal Neoplasms and Neoplasms, run by Shenzhen Hornetcorn Bio-technology Company, LTD at 1 site in China.
Trial summary
This study evaluates the safety and efficacy of D-CIK immune cells combined with chemotherapy after resection of esophageal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Neoplasms, Neoplasms, Digestive System Neoplasms
- What is being tested?
- Paclitaxel, DC-CIK and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old;
- Clinical diagnosis of esophageal cancer patients,tumor TNM stageII-III;
- Patients who can accept curative operations;
- Patients who have a life expectancy of at least 3 months; .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.
Zhiyuan Wang, Professor contact
China1 site, 1 recruiting
- Recruiting
Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Zhiyuan Wang, wangzhiyuan@hornetcorn.com
About this study
Official title: Phase II Clinical Study of Patients Randomized, Open, Controlled Evaluation of Autologous Tumor Tissue Antigen Sensitized DC-CIK Cells Combined With Chemotherapy in the Treatment of Patients With Esophageal Resection
This study evaluates the safety and efficacy of D-CIK immune cells combined with chemotherapy after resection of esophageal cancer
Read the detailed description
60 patients of esophageal cancer with TNM stage of tumor stage II-III,who had received surgery and kept their tumor tissue, will be randomly divided into group A (receive cancer tissue antigen sensitized D-CIK immune cells in combination with chemotherapy treatment) or group B (just receive chemotherapy), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of autologous antigen-sensitized DC-CIK cells treatment (every 4 weeks) and chemotherapy. Patients in group B will receive only 3 cycles chemotherapy.
- Being tested
- Paclitaxel, DC-CIK, Cisplatin
- Medical subject headings
- Esophageal Neoplasms, Neoplasms, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called TP
Paclitaxel 175mg/m2 IV over 2 hours,day 1; Repeat every 3 weeks;regimen for 3 cycles
DC-CIKBiological
Antigen-sensitized DC-CIK 8×10^9 autologous tumor lysate pulsed D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.
CisplatinDrug
Cisplatin 30mg/m2 IV on 1-3 days, Repeat every 3 weeks;regimen for 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| DC-CIK | Experimental | After accepting chemotherapy according to guidelines,patients will receive 3 cycles of autologous DC-CIK treatment. Receives: Drug: Paclitaxel; Biological: DC-CIK; Drug: Cisplatin |
| Chemotherapy | Sham comparator | After the Chemotherapy by Paclitaxel and Cisplatin, patients will just regularly follow up. Receives: Drug: Paclitaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The time of randomization begins to cause the death of any cause
Measured: 3 years
Secondary outcomes (3)
Progress-free survival
The time of randomization begins to tumor progression
Measured: 3 years
Quality of life (QOL)
Assess the quality of life of patients
Measured: 3 years
Phenotypic analysis of T cells
The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies 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
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Zhiyuan Wang, Professor, Study chair, Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644863
- Sponsor's protocol ID
- HYK-esophageal cancer
- Status last verified
- Dec 2015
- First submitted
- 28 Dec 2015
- Last updated
- 24 May 2016
- 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 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Patients Randomized, Open, Controlled Evaluation of Autologous Tumor Tissue Antigen Sensitized DC-CIK Cells Combined With Chemotherapy in the Treatment of Patients With Esophageal Resection
- ClinicalTrials.gov ID
- NCT02644863
- Acronym / sponsor ID
- HYK-esophageal cancer
- 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
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 1 Jan 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.
This study evaluates the safety and efficacy of D-CIK immune cells combined with chemotherapy after resection of esophageal cancer
Detailed description
60 patients of esophageal cancer with TNM stage of tumor stage II-III,who had received surgery and kept their tumor tissue, will be randomly divided into group A (receive cancer tissue antigen sensitized D-CIK immune cells in combination with chemotherapy treatment) or group B (just receive chemotherapy), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of autologous antigen-sensitized DC-CIK cells treatment (every 4 weeks) and chemotherapy. Patients in group B will receive only 3 cycles chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DC-CIK | Experimental | Drug: Paclitaxel, Biological: DC-CIK, Drug: CisplatinAfter accepting chemotherapy according to guidelines,patients will receive 3 cycles of autologous DC-CIK treatment. |
| Chemotherapy | Sham comparator | Drug: Paclitaxel, Drug: CisplatinAfter the Chemotherapy by Paclitaxel and Cisplatin, patients will just regularly follow up. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 years old;
- Clinical diagnosis of esophageal cancer patients,tumor TNM stageII-III;
- Patients who can accept curative operations;
- Patients who have a life expectancy of at least 3 months; .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 |
|---|---|---|
| PaclitaxelAlso: TPPaclitaxel 175mg/m2 IV over 2 hours,day 1; Repeat every 3 weeks;regimen for 3 cycles | Drug | Chemotherapy, DC-CIK |
| DC-CIKAntigen-sensitized DC-CIK 8×10^9 autologous tumor lysate pulsed D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32. | Biological | DC-CIK |
| CisplatinCisplatin 30mg/m2 IV on 1-3 days, Repeat every 3 weeks;regimen for 3 cycles | Drug | Chemotherapy, DC-CIK |
Primary outcome
Overall survival
Time frame: 3 years
The time of randomization begins to cause the death of any cause
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 year
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.
Zhiyuan Wang, Professor contact
Zhiyuan Wang, Professor study chair
Affiliated Tumor Hospital of Guangzhou Medical University 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 Paclitaxel, DC-CIK and Cisplatin in people with Esophageal Neoplasms 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 4 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 Zhiyuan Wang, Professor (wangzhiyuan@hornetcorn.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.