Pancreatic Cancer Research

Clinical trialObsUnknown

Evaluation of Killing Activity of Expanded Natural Killer Cells From Blood in Patients With Pancreatic Cancer

Ex Vivo Expansion of Natural Killer Cells From Blood in Patients With Pancreatic Cancer and the Evaluation of Killing Activity of Expanded Natural Killer Cells

Outcome
Outcome unknown
Phase
Obs
Status
Unknown
Study type
Observational
Start
July 2016
Expected end
October 2019
Enrollment
100 participants
Sites
1
Primary outcomes
NK cell activity
Sponsor
Other
Results posted
No
Last update
11 September 2018

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Brief summary public domain (ClinicalTrials.gov)

Pancreatic cancer, one of the deadliest epithelial malignancies, has a 5-year survival rate of only about 8%. The mortality rate has decreased slightly, but the incidence rate has been steadily increasing, and it is predicted to be the second leading cause of cancer mortality in 2030. Early diagnosis of pancreatic cancer and the development of innovative therapies are needed, and various basic and clinical studies based on pancreatic cancer biology are underway. Recently, studies on the effect of natural killer (NK) cells on cancer progression and the development of therapeutic agents using them have been actively conducted. NK cells are a component of innate lymphoid cells, accounting for approximately 5-15% of total peripheral blood mononuclear cells (PBMC).

Detailed description public domain (ClinicalTrials.gov)

Investigators will apply a new method to evaluate the activity of NK cells in pancreatic cancer patients, and to analyze the correlation with the progression of the tumor and the prognosis of the patient. And investigators will analyze the multifactorial factors affecting the activity of NK cells and conducted this study to help establish new diagnostic and therapeutic strategies for pancreatic cancer.

Intervention public domain (ClinicalTrials.gov)

Diagnostic_Test: Receptor specific activation method. NK cell was incubated with P815-ULBP1+CD48 cells that trigger NK cell synergy via NKG2D and 2B4

Arm public domain (ClinicalTrials.gov)

Conventional Activation method (): NK cell was incubated with either K562 cells

Arm public domain (ClinicalTrials.gov)

Receptor specific activation method (): NK cell was incubated with P815-ULBP1+CD48 cells that trigger NK cell synergy via NKG2D and 2B4

Primary outcome public domain (ClinicalTrials.gov)

NK cell activity. In order to compare the activity of NK cells according to the activation method, NK cells obtained from the blood of participants will be analyzed. Investigates will use two methods to analysis the activity of NK cell by FACS (Fluorescence-activated cell sorting). The degree of expression of CD107a on the cell surface and the degree of IFN-γ secretion will be compared by FACS. Time frame: 1 month before operation.

Secondary outcome public domain (ClinicalTrials.gov)

Tumor recurrence. Time frame: two year after tumor diagnosis.

Secondary outcome public domain (ClinicalTrials.gov)

Survival of participants. Time frame: two year after tumor diagnosis.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: * The patient who is admitted to the pancreatic surgery department for the treatment of pancreas tumor * Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up. * Life expectancy of at least 6 months based on discretion of treating * Adequate hematologic function defined by the following laboratory parameters: Hemoglobin \> 100, Platelet count \> 100 and Absolute granulocyte count \> 1.5. Exclusion Criteria: * Patients who received preoperative chemotherapy or radiotherapy. * Previous or concurrent malignancies. * Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure, unstable angina, serous infection.

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 100 participants (estimated).