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| Name | Class |
|---|---|
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DC-CIK | Experimental | After accepting chemotherapy according to guidelines,patients will receive 3 cycles of autologous DC-CIK treatment. |
|
| Chemotherapy | Sham Comparator | After the Chemotherapy by Paclitaxel and Cisplatin, patients will just regularly follow up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel 175mg/m2 IV over 2 hours,day 1; Repeat every 3 weeks;regimen for 3 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time of randomization begins to cause the death of any cause | 3 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiyuan Wang, Professor | Contact | wangzhiyuan@hornetcorn.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhiyuan Wang, Professor | Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Tumor Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| DC-CIK | Biological | 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 | Drug | Cisplatin 30mg/m2 IV on 1-3 days, Repeat every 3 weeks;regimen for 3 cycles |
|
| 3 years |
| Phenotypic analysis of T cells | The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell | 1 year |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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