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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02929797
Acronym
AKT
Enrollment
72
Registered
2016-10-11
Start date
2016-08-31
Completion date
2019-08-31
Last updated
2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

pancreatic cancer

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.

Interventions

BIOLOGICALCD8+NKG2D+ AKT Cell

AKT: CD8+NKG2D+ AKT cell

DRUGGemcitabine

gemcitabine

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Disease-free survival1 year

Secondary

MeasureTime frame
Overall Survival3 years
immune indices1 year
Quality of life3 years

Countries

China

Contacts

Primary Contacthongxia Wang, Dr.
whx365@126.com8621-63240090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026