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

Pancreatic Ductal Adenocarcinoma Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02929797
• Other study ID #: CD8+NKG2D+ AKT
• Status: Recruiting
• Phase: Phase 0
• First received: October 7, 2016
• Last updated: October 10, 2016
• Start date: August 2016
• Est. completion date: August 2019

Study information

• Verified date: October 2016
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: hongxia Wang, Dr.
• Phone: 8621-63240090
• Email: whx365[@]126.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial Summary

A Prospective Study on the Efficacy and Safety of CD8+NKG2D+ AKT cell immunotherapy to the pancreatic cancer patients treated with adjuvant chemotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: August 2019
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Biological:
• CD8+NKG2D+ AKT Cell
AKT: CD8+NKG2D+ AKT cell

Drug:
• Gemcitabine
gemcitabine

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai
China	Shanghai General Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		1 year	Yes
Secondary	Overall Survival		3 years	Yes
Secondary	immune indices		1 year	Yes
Secondary	Quality of life		3 years	Yes