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A Randomized, Double Blinding, Plancebo-Controlled Clinical Trials of CD8+NKG2D+ AKT cell immunotherapy to the panreatic cancer patients treated with adjuvant chemotherapy

A Randomized, Double Blinding, Plancebo-Controlled Clinical Trials of CD8+NKG2D+ AKT cell immunotherapy to the panreatic cancer patients treated with adjuvant chemotherapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-15007480
Enrollment
Unknown
Registered
2015-11-30
Start date
2016-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

pancreatic ductal adenocarcinoma

Interventions

Control Group:surgical resection+Gemcitabine+placebo
Study Group:surgical resection+Gemcitabine+AKT cell

Sponsors

Shanghai First Peoples' Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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 survival;

Secondary

MeasureTime frame
Overall Survival;Safety;Quality of life;Immune index;Biological marker;

Countries

China

Contacts

Public ContactHongxia Wang

Shanghai First Peoples' Hospital

whx365@126.com+86 13524491606

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026