Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer
NCT ID: NCT01691664
Last Updated: 2019-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2012-09-30
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Only radiation therapy
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.
Only radiation therapy
Patients only radiation therapy after surgery
Radiation therapy plus DC-CIK cellular therapy
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.
Radiation therapy plus DC-CIK cellular therapy
Patients receive radiation therapy plus DC-CIK cellular therapy after surgery
Interventions
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Only radiation therapy
Patients only radiation therapy after surgery
Radiation therapy plus DC-CIK cellular therapy
Patients receive radiation therapy plus DC-CIK cellular therapy after surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Jun Ren MD, PhD
Director, Capital Medical University Cancer Center
Principal Investigators
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Jun Ren, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Capital Medical University Cancer Center
Locations
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Beijing Shijitan Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jun Ren, MD, PhD
Role: primary
Other Identifiers
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JR-02
Identifier Type: -
Identifier Source: org_study_id
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