DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer

Clinical Research of Genetically Modified Dendritic Cells in Combination With Cytokine-induced Killer Cell Treatment in Middle and Advanced Esophagus Cancer Patients

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.

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)