Immunotherapy Of CD8+NKG2D+ AKT Cell With Chemotherapy To Pancreatic Cancer

Study Overview

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

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

N/A

Pancreatic Ductal Adenocarcinoma

BIOLOGICAL: CD8+NKG2D+ AKT Cell
DRUG: Gemcitabine

CD8+NKG2D+ AKT

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-10-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-10-10
First Submitted that Met QC Criteria 2016-10-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-10-11
First Posted (ESTIMATED) 2016-10-11	Results First Posted N/A	Last Verified 2016-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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 DRUG: Gemcitabine gemcitabine
ACTIVE_COMPARATOR: gemcitabine gemcitabine hydrochloride dose 1000mg/M2 d1,8,15，q4w ×6 Drug: gemcitabine	BIOLOGICAL: CD8+NKG2D+ AKT Cell AKT: CD8+NKG2D+ AKT cell DRUG: Gemcitabine gemcitabine

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

DRUG: Gemcitabine

gemcitabine

ACTIVE_COMPARATOR: gemcitabine

gemcitabine hydrochloride dose 1000mg/M2 d1,8,15，q4w ×6 Drug: gemcitabine

BIOLOGICAL: CD8+NKG2D+ AKT Cell

AKT: CD8+NKG2D+ AKT cell

DRUG: Gemcitabine

gemcitabine

Primary Outcome Measures	Measure Description	Time Frame
Disease-free survival		1 year

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: hongxia Wang, Dr.

Phone Number: 8621-63240090

Email: whx365@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Investigators

PRINCIPAL_INVESTIGATOR: hongxia Wang, Dr., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record