Immunotherapy of CD8+NKG2D+ AKT Cell With Chemotherapy to Pancreatic Cancer
NCT ID: NCT02929797
Last Updated: 2016-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
72 participants
INTERVENTIONAL
2016-08-31
2019-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AKT + gemcitabine
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
CD8+NKG2D+ AKT Cell
AKT: CD8+NKG2D+ AKT cell
Gemcitabine
gemcitabine
gemcitabine
gemcitabine hydrochloride dose 1000mg/M2 d1,8,15，q4w ×6 Drug: gemcitabine
Gemcitabine
gemcitabine
Interventions
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CD8+NKG2D+ AKT Cell
AKT: CD8+NKG2D+ AKT cell
Gemcitabine
gemcitabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
INDUSTRY
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Hongxia Wang
Deputy Director of Oncology
Principal Investigators
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hongxia Wang, Dr.
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CD8+NKG2D+ AKT
Identifier Type: -
Identifier Source: org_study_id
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