Autologous Tumor Tissue Antigen-sensitized DC-CIK Cells Combined With Chemotherapy for Esophageal Cancer

Study Overview
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Brief Summary
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This study evaluates the safety and efficacy of D-CIK immune cells combined with chemotherapy after resection of esophageal cancer

Detailed Description
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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.

Official Title
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Phase II Clinical Study of Patients Randomized, Open, Controlled Evaluation of Autologous Tumor Tissue Antigen Sensitized DC-CIK Cells Combined With Chemotherapy in the Treatment of Patients With Esophageal Resection

Conditions
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Esophageal Neoplasms, Neoplasms, Digestive System Neoplasms, Esophageal Cancer

Intervention / Treatment
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* Drug: Paclitaxel
* Biological: DC-CIK
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years old; Clinical diagnosis of esophageal cancer patients,tumor TNM stageII-III; Patients who can accept curative operations; Patients who have a life expectancy of at least 3 months; .Eastern Cooperative Oncology Group (ECOG) performance status was 0-2. Exclusion Criteria: White blood cell <3 x 10^9/L,Platelet count <75 x 10^9/L;BUN and Cr more than normal limits on 3.0 times ; Known or suspected allergy to the investigational agent or any agent given in association with this trial; Pregnant or lactating patients; Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection; Patients who are suffering from serious autoimmune disease; Patients who had used long time or are using immunosuppressant; Patients who had active infection; Prior use of any anti-cancer treatment in 30 days; Now or recently will join another experimental clinical study ; History of organ allograft; Other situations that the researchers considered unsuitable for this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DC-CIK<br>After accepting chemotherapy according to guidelines,patients will receive 3 cycles of autologous DC-CIK treatment. | Drug: Paclitaxel<br>* Paclitaxel 175mg/m2 IV over 2 hours,day 1; Repeat every 3 weeks;regimen for 3 cycles<br>* Other names: TP;Biological: DC-CIK<br>* 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.<br>Drug: Cisplatin<br>* Cisplatin 30mg/m2 IV on 1-3 days, Repeat every 3 weeks;regimen for 3 cycles<br>|
| Sham Comparator: Chemotherapy<br>After the Chemotherapy by Paclitaxel and Cisplatin, patients will just regularly follow up. | Drug: Paclitaxel<br>* Paclitaxel 175mg/m2 IV over 2 hours,day 1; Repeat every 3 weeks;regimen for 3 cycles<br>* Other names: TP;Drug: Cisplatin<br>* Cisplatin 30mg/m2 IV on 1-3 days, Repeat every 3 weeks;regimen for 3 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The time of randomization begins to cause the death of any cause | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress-free survival | The time of randomization begins to tumor progression | 3 years | 
| Quality of life (QOL) | Assess the quality of life of patients | 3 years | 
| Phenotypic analysis of T cells | The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell | 1 year |