Esophageal CancerNCT01691664
Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer
A study testing Only radiation therapy and Radiation therapy plus DC-CIK cellular therapy in people with Esophageal Cancer, run by Capital Medical University at 1 site in China.
Trial summary
Cytokine-induced killer (CIK) cells show cytolytic activity against tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining Radiation therapy with adoptive cellular therapy after surgery may be more effective than uses radiation therapy alone in treating esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Only radiation therapy and Radiation therapy plus DC-CIK cellular therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Jun 2022
- 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 esophageal carcinoma
- Tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease
- Prior en bloc resection, with curative intent, of all known tumor
- No metastatic disease
- Age: > 18
- Karnofsky performance status ≥ 70
Show all 11Show fewer
- At least 3 weeks since prior surgery
- 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
- All patients must be evaluated by a radiation oncologist prior to enrollment to ensure patient is appropriate for radiotherapy
- Informed consent signed
Who cannot join
- Patients with metastatic disease.
- Patients who are pregnant or nursing.
- Patients with poor bone marrow, liver and kidney functions, which would make radiation therapy intolerable
- Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038
Jun Ren, MD, PhD, 86-10-63926317
About this study
Cytokine-induced killer (CIK) cells show cytolytic activity against tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining Radiation therapy with adoptive cellular therapy after surgery may be more effective than uses radiation therapy alone in treating esophageal cancer.
- Conditions
- Esophageal Cancer
- Being tested
- Only radiation therapy, Radiation therapy plus DC-CIK cellular therapy
- Keywords
- Esophageal Cancer, DC-CIK, immunotherapy, cellular therapy, radiation therapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Only radiation therapyRadiation
Patients only radiation therapy after surgery
Radiation therapy plus DC-CIK cellular therapyOther
Patients receive radiation therapy plus DC-CIK cellular therapy after surgery
| Study group | Role | What they receive |
|---|---|---|
| Only radiation therapy | Active comparator | 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 50Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. Receives: Radiation: Only radiation therapy |
| Radiation therapy plus DC-CIK cellular therapy | Experimental | 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 50Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
DC-CIK cellular therapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before radiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the radiation intermittent period. Receives: Other: Radiation therapy plus DC-CIK cellular therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 4 years
Secondary outcomes (1)
quality of life
Measured: Initial assessment → months 1,3,6 and 12
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 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
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
- Investigators
- Jun Ren, MD, PhD, Principal investigator, Capital Medical University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691664
- Sponsor's protocol ID
- JR-02
- Status last verified
- Oct 2019
- First submitted
- 18 Sep 2012
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01691664
- Acronym / sponsor ID
- JR-02
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer, DC-CIK, immunotherapy, cellular therapy, radiation therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- 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.
Cytokine-induced killer (CIK) cells show cytolytic activity against tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining Radiation therapy with adoptive cellular therapy after surgery may be more effective than uses radiation therapy alone in treating esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Only radiation therapy | Active comparator | Radiation: Only radiation therapyRadiotherapy: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 50Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. |
| Radiation therapy plus DC-CIK cellular therapy | Experimental | Other: Radiation therapy plus DC-CIK cellular therapyRadiotherapy: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 50Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. DC-CIK cellular therapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before radiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the radiation intermittent period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- cytologically or histologically confirmed esophageal carcinoma
- Tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease
- Prior en bloc resection, with curative intent, of all known tumor
- No metastatic disease
- Age: > 18
Key exclusion criteria (4 listed)
- Patients with metastatic disease.
- Patients who are pregnant or nursing.
- Patients with poor bone marrow, liver and kidney functions, which would make radiation therapy intolerable
- Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
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 |
|---|---|---|
| Only radiation therapyPatients only radiation therapy after surgery | Radiation | Only radiation therapy |
| Radiation therapy plus DC-CIK cellular therapyPatients receive radiation therapy plus DC-CIK cellular therapy after surgery | Other | Radiation therapy plus DC-CIK cellular therapy |
Primary outcome
Disease free survival
Time frame: 4 years
1 secondary outcome
quality of life
Time frame: Initial assessment → months 1,3,6 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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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.
Jun Ren, MD, PhD principal investigator
Capital Medical University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Only radiation therapy and Radiation therapy plus DC-CIK cellular therapy in people with Esophageal Cancer, 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 11 inclusion and 4 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 4 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Ren, MD,PhD (86-10-63926317, renjun9688@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 4 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 4 Nov 2019.