Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer
Conditions
Esophageal Carcinoma
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Locally advanced esophageal carcinoma, DC-CIK, Immunotherapy
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: concurrent chemoradiotherapy plus DC-CIK immunotherapy Type: Other
Name: Concurrent chemoradiation only Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Capital Medical University Cancer Center
Beijing, Beijing, China
Status: Recruiting
Contact: Jun Ren, MD, PhD - 86-10-63926317 - renjun9688@yahoo.com
Start Date
September 2012
Completion Date
September 2017
Sponsors
Capital Medical University
Source
Capital Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page