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

Early Phase 1

• Conditions: Pancreatic Ductal Adenocarcinoma
• Interventions: Biological: CD8+NKG2D+ AKT Cell; Drug: Gemcitabine

• Registration Number: NCT02929797
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Status Verified: 2016-10
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-10
• Last Update Submitted: 2016-10-10
• Study First Posted: 2016-10-11
• Last Update Posted: 2016-10-11
• Primary Completion: 2017-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AKT + gemcitabine	CD8+NKG2D+ AKT Cell	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
AKT + gemcitabine	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
gemcitabine	Gemcitabine	gemcitabine hydrochloride dose 1000mg/M2 d1,8,15，q4w ×6 Drug: gemcitabine

Primary Outcome Measures

Name	Time	Method
Disease-free survival	1 year

Secondary Outcome Measures

Name	Time	Method
Quality of life	3 years
Overall Survival	3 years
immune indices	1 year

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, China