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

A Randomized, Double Blinding, Placebo-Controlled Clinical Trials of CD8+NKG2D+ AKT Cell Immunotherapy to the Pancreatic Cancer Patients Treated With Adjuvant Chemotherapy

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

Study Overview

• Status: Unknown
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Biological: CD8+NKG2D+ AKT Cell; Drug: Gemcitabine

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 201620
    • Recruiting
    • Shanghai General Hospital
    • Contact: Shupeng Guo, Dr; Phone Number: 18817943845; Email: gsp88@foxmail.com
  • Shanghai
    • Shanghai, Shanghai, China, 201620
      • Recruiting
      • Shanghai General Hospital
      • Contact: Shupeng Guo, Dr; Phone Number: 18817943845; Email: gsp88@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: AKT; Drug: Gemcitabine; gemcitabine; Other Names: GEM
Active Comparator: gemcitabine; gemcitabine hydrochloride dose 1000mg/M2 d1,8,15，q4w ×6 Drug: gemcitabine	Drug: Gemcitabine; gemcitabine; Other Names: GEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	3 years
Quality of life	3 years
immune indices	1 year

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
• Investigators: Principal Investigator: hongxia Wang, Dr., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: October 10, 2016
• First Posted (Estimate): October 11, 2016

Study Record Updates

• Last Update Posted (Estimate): October 11, 2016
• Last Update Submitted That Met QC Criteria: October 10, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: pancreatic cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine
• Other Study ID Numbers: CD8+NKG2D+ AKT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED