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

Capital Medical University

Status: Completed

Conditions: Esophageal Carcinoma

Treatments: Other: concurrent chemoradiotherapy plus DC-CIK immunotherapy; Other: Concurrent chemoradiation only

Study type: Interventional

Funder types: Other

Identifiers

NCT01691625

JR-01

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

concurrent chemoradiotherapy plus DC-CIK immunotherapy

Experimental group

Description:

patients will receive concurrent chemoradiotherapy plur DC-CIK immunotherapy

Treatment:

Other: concurrent chemoradiotherapy plus DC-CIK immunotherapy

Concurrent chemoradiation only

Active Comparator group

Description:

patients will receive concurrent chemoradiotherapy only

Treatment:

Other: Concurrent chemoradiation only