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

Shanghai Jiao Tong University

Status and phase: Unknown; Early Phase 1

Conditions: Pancreatic Ductal Adenocarcinoma

Treatments: Drug: Gemcitabine; Biological: CD8+NKG2D+ AKT Cell

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02929797

CD8+NKG2D+ AKT

Details and patient eligibility

About

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

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

AKT + gemcitabine

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

Biological: CD8+NKG2D+ AKT Cell

gemcitabine

Active Comparator group

Description:

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

Treatment:

Drug: Gemcitabine