Clinical trial NCT02929797: Immunotherapy of CD8+NKG2D+ AKT Cell With Chemotherapy to Pancreatic Cancer
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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: pancreatic cancer
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
First posted: 2016-10-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Disease-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years
measure: immune indices
timeFrame: 1 year
measure: Quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: hongxia Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: