Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: 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. |
Radiation: Only radiation therapy
Patients only radiation therapy after surgery
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Experimental: 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. |
Other: Radiation therapy plus DC-CIK cellular therapy
Patients receive radiation therapy plus DC-CIK cellular therapy after surgery
|
Outcome Measures
Primary Outcome Measures
- Disease free survival [4 years]
Secondary Outcome Measures
- quality of life [Initial assessment → months 1,3,6 and 12]
Other Outcome Measures
- Immunological assessment [Initial assessment, months 1,3,6and 12]
Eligibility Criteria
Criteria
Inclusion Criteria:
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cytologically or histologically confirmed esophageal carcinoma
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Tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease
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Prior en bloc resection, with curative intent, of all known tumor
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No metastatic disease
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Age: > 18
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Karnofsky performance status ≥ 70
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At least 3 weeks since prior surgery
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Normal functions of heart, lung, liver, kidney and bone marrow
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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
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All patients must be evaluated by a radiation oncologist prior to enrollment to ensure patient is appropriate for radiotherapy
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Informed consent signed
Exclusion Criteria:
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Patients with metastatic disease.
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Patients who are pregnant or nursing.
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Patients with poor bone marrow, liver and kidney functions, which would make radiation therapy intolerable
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Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Beijing Shijitan Hospital | Beijing | Beijing | China | 100038 |
Sponsors and Collaborators
- Capital Medical University
Investigators
- Principal Investigator: Jun Ren, MD, PhD, Capital Medical University Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JR-02