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Trial record 3 of 33 for:    nkg2d

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02929797
Recruitment Status : Unknown
Verified October 2016 by Hongxia Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : October 11, 2016
Last Update Posted : October 11, 2016
Sponsor:
Collaborator:
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Information provided by (Responsible Party):
Hongxia Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Tracking Information
First Submitted Date  ICMJE October 7, 2016
First Posted Date  ICMJE October 11, 2016
Last Update Posted Date October 11, 2016
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2016)
Disease-free survival [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2016)
  • Overall Survival [ Time Frame: 3 years ]
  • immune indices [ Time Frame: 1 year ]
  • Quality of life [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunotherapy of CD8+NKG2D+ AKT Cell With Chemotherapy to Pancreatic Cancer
Official Title  ICMJE A Randomized, Double Blinding, Placebo-Controlled Clinical Trials of CD8+NKG2D+ AKT Cell Immunotherapy to the Pancreatic Cancer Patients Treated With Adjuvant Chemotherapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Ductal Adenocarcinoma
Intervention  ICMJE
  • Biological: CD8+NKG2D+ AKT Cell
    AKT: CD8+NKG2D+ AKT cell
    Other Name: AKT
  • Drug: Gemcitabine
    gemcitabine
    Other Name: GEM
Study Arms  ICMJE
  • Experimental: 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
    Interventions:
    • Biological: CD8+NKG2D+ AKT Cell
    • Drug: Gemcitabine
  • Active Comparator: gemcitabine
    gemcitabine hydrochloride dose 1000mg/M2 d1,8,15,q4w ×6 Drug: gemcitabine
    Intervention: Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 10, 2016)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02929797
Other Study ID Numbers  ICMJE CD8+NKG2D+ AKT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hongxia Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Sponsor  ICMJE Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators  ICMJE Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Investigators  ICMJE
Principal Investigator: hongxia Wang, Dr. Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
PRS Account Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP