Clinical trial NCT02644863: Autologous Tumor Tissue Antigen-sensitized DC-CIK Cells Combined With Chemotherapy for Esophageal Cancer
Official title: Phase II Clinical Study of Patients Randomized, Open, Controlled Evaluation of Autologous Tumor Tissue Antigen Sensitized DC-CIK Cells Combined With Chemotherapy in the Treatment of Patients With Esophageal Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Neoplasms
Neoplasms
Digestive System Neoplasms
Esophageal Cancer
Lead sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD
Sponsor class: INDUSTRY
Collaborators: name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
First posted: 2016-01-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety and efficacy of D-CIK immune cells combined with chemotherapy after resection of esophageal cancer

Detailed description: 60 patients of esophageal cancer with TNM stage of tumor stage II-III,who had received surgery and kept their tumor tissue, will be randomly divided into group A (receive cancer tissue antigen sensitized D-CIK immune cells in combination with chemotherapy treatment) or group B (just receive chemotherapy), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of autologous antigen-sensitized DC-CIK cells treatment (every 4 weeks) and chemotherapy. Patients in group B will receive only 3 cycles chemotherapy.

Eligibility criteria: Inclusion Criteria:

* 18-75 years old;
* Clinical diagnosis of esophageal cancer patients,tumor TNM stageII-III;
* Patients who can accept curative operations;
* Patients who have a life expectancy of at least 3 months; .Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.

Exclusion Criteria:

* White blood cell \<3 x 10\^9/L,Platelet count \<75 x 10\^9/L;BUN and Cr more than normal limits on 3.0 times ;
* Known or suspected allergy to the investigational agent or any agent given in association with this trial;
* Pregnant or lactating patients;
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
* Patients who are suffering from serious autoimmune disease;
* Patients who had used long time or are using immunosuppressant;
* Patients who had active infection;
* Prior use of any anti-cancer treatment in 30 days;
* Now or recently will join another experimental clinical study ;
* History of organ allograft;
* Other situations that the researchers considered unsuitable for this study

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Progress-free survival
timeFrame: 3 years
measure: Quality of life (QOL)
timeFrame: 3 years
measure: Phenotypic analysis of T cells
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Affiliated Tumor Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center
name: Zhiyuan Wang, Professor
role: STUDY_CHAIR
References: