Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Radiation: Only radiation therapy
* Other: Radiation therapy plus DC-CIK cellular therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Only radiation therapy<br>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. | Radiation: Only radiation therapy<br>* Patients only radiation therapy after surgery<br>|
| Experimental: Radiation therapy plus DC-CIK cellular therapy<br>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. | Other: Radiation therapy plus DC-CIK cellular therapy<br>* Patients receive radiation therapy plus DC-CIK cellular therapy after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | Initial assessment → months 1,3,6 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Cancer, DC-CIK, immunotherapy, cellular therapy, radiation therapy