Immunotherapy of CD8+NKG2D+ AKT Cell With Chemotherapy to Pancreatic Cancer

Study Overview
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Brief Summary
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A Prospective Study on the Efficacy and Safety of CD8+NKG2D+ AKT cell immunotherapy to the pancreatic cancer patients treated with adjuvant chemotherapy.

Official Title
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A Randomized, Double Blinding, Placebo-Controlled Clinical Trials of CD8+NKG2D+ AKT Cell Immunotherapy to the Pancreatic Cancer Patients Treated With Adjuvant Chemotherapy

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Biological: CD8+NKG2D+ AKT Cell
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Diagnosed as stage II-III pancreatic ductal adenocarcinoma patients by pathologic histology; 2. Pancreatic cancer after radical resection; 3. Eastern Cooperative Oncology Group Performance Status less than 2; 4. Without radiotherapy or neoadjuvant chemotherapy; 5. The man or the gestation and lactation women Age between 18 to 80 years old; 6. Bone marrow functioned well: ANC more than 1.5*10^9/ L, PLT more than 100*10^9/LHgb more than 9 g/dL; 7. Blood biochemical indicators: AST（SGOT）less than 1.5 ULNALT（SGPT）less than 1.5 ULN, TBIL less than 1.5 ULN; 8. PT and PPT are in normal ranges; 9. Three months prior to clinical research did not receive any other clinical research trials; 10. patients are voluntary, and willing to sign informed consent. Exclusion Criteria: 1. Patients with other malignant tumors in the past five years; 2. Active viral or bacterial infection and cannot be controlled with appropriate anti-infection treatment; 3. Known as HIV infection, active hepatitis B virus or hepatitis C virus infection; 4. Known allergy to any kind of component of study drugs; 5. History of connective tissue disease(Such as lupus, scleroderma, nodular arteritis); 6. Patients with a history of interstitial pneumoniaSlowly progressive difficulty in breathing and hoose Sarcoidosissilicosis Fibrose pulmonaire idiopathiquehylactic pneumonia or A variety of allergy; 7. Suffering from mental illness or other illness, such as heart or lung disease, diabetes, etc. that can not be controlled, and can not cope with study treatment and monitoring requirements; 8. At the same time Patients participate in any other use of interventional medicine clinical research or checkers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: AKT + gemcitabine<br>gemcitabine dose 1000mg/M^2, d1,8,15，q4w ×6 AKT 5*10^8/M^2, d16,q4w ×6 Drug: gemcitabine Biological: AKT, CD8+NKG2D+ AKT Cell | Biological: CD8+NKG2D+ AKT Cell<br>* AKT: CD8+NKG2D+ AKT cell<br>* Other names: AKT;Drug: Gemcitabine<br>* gemcitabine<br>* Other names: GEM;|
| Active Comparator: gemcitabine<br>gemcitabine hydrochloride dose 1000mg/M2 d1,8,15，q4w ×6 Drug: gemcitabine | Drug: Gemcitabine<br>* gemcitabine<br>* Other names: GEM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 3 years | 
| immune indices |  | 1 year | 
| Quality of life |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer