DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer
This trial is active, not recruiting.
|Treatment||adenovirus-transfected autologous dc vaccine plus cik cells|
|Phase||phase 1/phase 2|
|Sponsor||Affiliated Hospital to Academy of Military Medical Sciences|
|Start date||August 2014|
|End date||August 2016|
|Trial size||30 participants|
|Trial identifier||NCT02693236, 307-CTC-DC/CIK-EC|
The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) combined with cytokine-induced killer (CIK) cells in patients with advanced esophagus cancer. Experimental recombinant adenovirus coded mRNA including MUC1 and Survivin that transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the researcher plan to perform the clinical trial.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
objective rate response (CR+PR) as measured by RECIST criteria
time frame: Time Frame: 4 weeks after DC/CIK treatment
number of participants with adverse events
time frame: Time Frame: 3 days within DC/CIK treatment
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - Histopathologically confirmed diagnosis of esophagus cancer - Age >18 years at time of consent - Received standardized treatment of Small-Cell Lung Cancer - Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks - KPS (Karnofsky performance scale) >60 - Patient's written informed consent - No severe viral or bacterial infections - Predicted survival >3 months Exclusion Criteria: - Serious dysfunction of vital organs(heart, liver or kidney) - History of autoimmune diseases - Pregnant and breast-feeding patient - Active or chronic infectious diseases - History of allergy or hypersensitivity to study product excipients - Currently participating in another clinical trial - Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks - Clinically relevant diseases or infections (HBV, HCV, HIV)
|Official title||Clinical Research of Genetically Modified Dendritic Cells in Combination With Cytokine-induced Killer Cell Treatment in Middle and Advanced Esophagus Cancer Patients|
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