Immunotherapy of CD8+NKG2D+ AKT Cell With Chemotherapy to Pancreatic Cancer (AKT)
Primary Purpose
Pancreatic Ductal Adenocarcinoma
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
CD8+NKG2D+ AKT Cell
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma focused on measuring pancreatic cancer
Eligibility Criteria
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.
Sites / Locations
- Shanghai General HospitalRecruiting
- Shanghai General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AKT + gemcitabine
gemcitabine
Arm Description
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
gemcitabine hydrochloride dose 1000mg/M2 d1,8,15,q4w ×6 Drug: gemcitabine
Outcomes
Primary Outcome Measures
Disease-free survival
Secondary Outcome Measures
Overall Survival
immune indices
Quality of life
Full Information
NCT ID
NCT02929797
First Posted
October 7, 2016
Last Updated
October 10, 2016
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
1. Study Identification
Unique Protocol Identification Number
NCT02929797
Brief Title
Immunotherapy of CD8+NKG2D+ AKT Cell With Chemotherapy to Pancreatic Cancer
Acronym
AKT
Official Title
A Randomized, Double Blinding, Placebo-Controlled Clinical Trials of CD8+NKG2D+ AKT Cell Immunotherapy to the Pancreatic Cancer Patients Treated With Adjuvant Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Prospective Study on the Efficacy and Safety of CD8+NKG2D+ AKT cell immunotherapy to the pancreatic cancer patients treated with adjuvant chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Ductal Adenocarcinoma
Keywords
pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AKT + gemcitabine
Arm Type
Experimental
Arm Description
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
Arm Title
gemcitabine
Arm Type
Active Comparator
Arm Description
gemcitabine hydrochloride dose 1000mg/M2 d1,8,15,q4w ×6 Drug: gemcitabine
Intervention Type
Biological
Intervention Name(s)
CD8+NKG2D+ AKT Cell
Other Intervention Name(s)
AKT
Intervention Description
AKT: CD8+NKG2D+ AKT cell
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
GEM
Intervention Description
gemcitabine
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
3 years
Title
immune indices
Time Frame
1 year
Title
Quality of life
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hongxia Wang, Dr.
Phone
8621-63240090
Email
whx365@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hongxia Wang, Dr.
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201620
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shupeng Guo, Dr
Phone
18817943845
Email
gsp88@foxmail.com
Facility Name
Shanghai General Hospital
City
Shanghai
ZIP/Postal Code
201620
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shupeng Guo, Dr
Phone
18817943845
Email
gsp88@foxmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Immunotherapy of CD8+NKG2D+ AKT Cell With Chemotherapy to Pancreatic Cancer
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