DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer

Affiliated Hospital to Academy of Military Medical Sciences30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophagus Cancer

Interventions

adenovirus-transfected autologous DC vaccine plus CIK cellsBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (1)

Affiliated Hospital to Academy of Military Medical Sciences

Beijing, China

Outcomes

Primary Outcomes

objective rate response (CR+PR) as measured by RECIST criteria

Time frame: Time Frame: 4 weeks after DC/CIK treatment

Secondary Outcomes

number of participants with adverse events

Time frame: Time Frame: 3 days within DC/CIK treatment

Data from ClinicalTrials.gov

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