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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

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.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Biological: CD8+NKG2D+ AKT Cell Drug: Gemcitabine Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Biological: CD8+NKG2D+ AKT Cell
AKT: CD8+NKG2D+ AKT cell
Other Name: AKT

Drug: Gemcitabine
gemcitabine
Other Name: GEM

Active Comparator: gemcitabine
gemcitabine hydrochloride dose 1000mg/M2 d1,8,15,q4w ×6 Drug: gemcitabine
Drug: Gemcitabine
gemcitabine
Other Name: GEM




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years ]
  2. immune indices [ Time Frame: 1 year ]
  3. Quality of life [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929797


Contacts
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Contact: hongxia Wang, Dr. 8621-63240090 whx365@126.com

Locations
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China, Shanghai
Shanghai General Hospital Recruiting
Shanghai, Shanghai, China, 201620
Contact: Shupeng Guo, Dr    18817943845    gsp88@foxmail.com   
China
Shanghai General Hospital Recruiting
Shanghai, China, 201620
Contact: Shupeng Guo, Dr    18817943845    gsp88@foxmail.com   
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Investigators
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Principal Investigator: hongxia Wang, Dr. Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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Responsible Party: Hongxia Wang, Deputy Director of Oncology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02929797    
Other Study ID Numbers: CD8+NKG2D+ AKT
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hongxia Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs