Esophageal Carcinoma
Conditions
Keywords
Locally advanced esophageal carcinoma, DC-CIK, Immunotherapy
Brief 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.
Interventions
OTHERconcurrent chemoradiotherapy plus DC-CIK immunotherapy
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.
OTHERConcurrent chemoradiation only
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.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the quality of life | initial assessment, months 1, 3, 6 and 12 |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival | 1 year |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immunological assessment | baseline, months 1, 3, 6 and 12 | Cytokine secretion and T cell populations are assessed. |
Countries
China
Outcome results
None listed