Esophageal CarcinomaNCT01691625
Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer
A study testing concurrent chemoradiotherapy plus DC-CIK immunotherapy and Concurrent chemoradiation only in people with Esophageal Carcinoma, run by Capital Medical University at 1 site in China.
Trial summary
The purpose of this study is to show if the adoptive cellular therapy with autologous dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent chemoradiation could improve the quality of life of the patients with locally advanced esophageal cancer, compared with concurrent chemoradiation only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Carcinoma
- What is being tested?
- concurrent chemoradiotherapy plus DC-CIK immunotherapy and Concurrent chemoradiation only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cytologically or histologically confirmed locally advanced esophageal carcinoma
- Age: > 18
- Karnofsky performance status ≥ 70
- At least one measurable tumor lesions according to the RECIST criteria.
- Normal functions of heart, lung, liver, kidney and bone marrow
- Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
- Informed consent signed
Who cannot join
- Patients with metastatic disease in the central nervous system (CNS).
- Patients who are pregnant or nursing.
- Patients with poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable
- Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
- coexisted morbidities that investigators believed not suitable for chemoradiation
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University Cancer Center
Beijing, Beijing Municipality, 100038
About this study
The purpose of this study is to show if the adoptive cellular therapy with autologous dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent chemoradiation could improve the quality of life of the patients with locally advanced esophageal cancer, compared with concurrent chemoradiation only.
- Conditions
- Esophageal Carcinoma
- Being tested
- concurrent chemoradiotherapy plus DC-CIK immunotherapy, Concurrent chemoradiation only
- Keywords
- Locally advanced esophageal carcinoma, DC-CIK, Immunotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concurrent chemoradiotherapy plus DC-CIK immunotherapyOther
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation.
DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before concurrent chemoradiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the Chemoradiation intermittent period.
Concurrent chemoradiation onlyOther
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation.
| Study group | Role | What they receive |
|---|---|---|
| concurrent chemoradiotherapy plus DC-CIK immunotherapy | Experimental | patients will receive concurrent chemoradiotherapy plur DC-CIK immunotherapy Receives: Other: concurrent chemoradiotherapy plus DC-CIK immunotherapy |
| Concurrent chemoradiation only | Active comparator | patients will receive concurrent chemoradiotherapy only Receives: Other: Concurrent chemoradiation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
the quality of life
Measured: initial assessment, months 1, 3, 6 and 12
Secondary outcomes (1)
progression-free survival
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 posted25 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2020
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ren MD, PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691625
- Sponsor's protocol ID
- JR-01
- Status last verified
- Feb 2024
- First submitted
- 17 Sep 2012
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01691625
- Acronym / sponsor ID
- JR-01
- Conditions
- Esophageal Carcinoma
- Keywords
- Locally advanced esophageal carcinoma, DC-CIK, Immunotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 25 Sep 2012 (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 purpose of this study is to show if the adoptive cellular therapy with autologous dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent chemoradiation could improve the quality of life of the patients with locally advanced esophageal cancer, compared with concurrent chemoradiation only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| concurrent chemoradiotherapy plus DC-CIK immunotherapy | Experimental | Other: concurrent chemoradiotherapy plus DC-CIK immunotherapypatients will receive concurrent chemoradiotherapy plur DC-CIK immunotherapy |
| Concurrent chemoradiation only | Active comparator | Other: Concurrent chemoradiation onlypatients will receive concurrent chemoradiotherapy only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- cytologically or histologically confirmed locally advanced esophageal carcinoma
- Age: > 18
- Karnofsky performance status ≥ 70
- At least one measurable tumor lesions according to the RECIST criteria.
- Normal functions of heart, lung, liver, kidney and bone marrow
Key exclusion criteria (5 listed)
- Patients with metastatic disease in the central nervous system (CNS).
- Patients who are pregnant or nursing.
- Patients with poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable
- Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
- coexisted morbidities that investigators believed not suitable for chemoradiation
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 |
|---|---|---|
| concurrent chemoradiotherapy plus DC-CIK immunotherapyRadiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation. DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before concurrent chemoradiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the Chemoradiation intermittent period. | Other | concurrent chemoradiotherapy plus DC-CIK immunotherapy |
| Concurrent chemoradiation onlyRadiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation. | Other | Concurrent chemoradiation only |
Primary outcome
the quality of life
Time frame: initial assessment, months 1, 3, 6 and 12
1 secondary outcome
progression-free survival
Time frame: 1 year
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 7 Feb 2024.
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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 study testing concurrent chemoradiotherapy plus DC-CIK immunotherapy and Concurrent chemoradiation only in people with Esophageal Carcinoma, run by Capital Medical University 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 5 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 7 Feb 2024. 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?
the quality of life (time frame: initial assessment, months 1, 3, 6 and 12). 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 7 Feb 2024.