This study evaluates the safety and efficacy of D-CIK immune cells combined with chemotherapy after resection of esophageal cancer
60 patients of esophageal cancer with TNM stage of tumor stage II-III,who had received surgery and kept their tumor tissue, will be randomly divided into group A (receive cancer tissue antigen sensitized D-CIK immune cells in combination with chemotherapy treatment) or group B (just receive chemotherapy), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of autologous antigen-sensitized DC-CIK cells treatment (every 4 weeks) and chemotherapy. Patients in group B will receive only 3 cycles chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Paclitaxel 175mg/m2 IV over 2 hours,day 1; Repeat every 3 weeks;regimen for 3 cycles
Antigen-sensitized DC-CIK 8×10\^9 autologous tumor lysate pulsed D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.
Cisplatin 30mg/m2 IV on 1-3 days, Repeat every 3 weeks;regimen for 3 cycles
Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGOverall survival
The time of randomization begins to cause the death of any cause
Time frame: 3 years
Progress-free survival
The time of randomization begins to tumor progression
Time frame: 3 years
Quality of life (QOL)
Assess the quality of life of patients
Time frame: 3 years
Phenotypic analysis of T cells
The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
Time frame: 1 year
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