Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer

Capital Medical University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Carcinoma

Interventions

concurrent chemoradiotherapy plus DC-CIK immunotherapyOTHER

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.

Concurrent chemoradiation onlyOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Capital Medical University Cancer Center

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

the quality of life

Time frame: initial assessment, months 1, 3, 6 and 12

Secondary Outcomes

progression-free survival

Time frame: 1 year

Data from ClinicalTrials.gov

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