Autologous Tumor Tissue Antigen-sensitized DC-CIK Cells Combined With Chemotherapy for Esophageal Cancer

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02644863
• Other study ID #: HYK-esophageal cancer
• Status: Recruiting
• Phase: Phase 2
• First received: December 28, 2015
• Last updated: May 23, 2016
• Start date: December 2015
• Est. completion date: May 2019

Study information

• Verified date: December 2015
• Source: Shenzhen Hornetcorn Bio-technology Company, LTD
• Contact: Zhiyuan Wang, Professor
• Email: wangzhiyuan[@]hornetcorn.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Esophageal Cancer
• Esophageal Neoplasms
• Gastrointestinal Neoplasms
• Neoplasms

Intervention

Drug:
• Paclitaxel
Paclitaxel 175mg/m2 IV over 2 hours,day 1; Repeat every 3 weeks;regimen for 3 cycles

Biological:
• DC-CIK
Antigen-sensitized DC-CIK 8×10^9 autologous tumor lysate pulsed D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.

Drug:
• Cisplatin
Cisplatin 30mg/m2 IV on 1-3 days, Repeat every 3 weeks;regimen for 3 cycles

Locations

Country	Name	City	State
China	Affiliated Tumor Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Hornetcorn Bio-technology Company, LTD	Affiliated Tumor Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The time of randomization begins to cause the death of any cause	3 years	No
Secondary	Progress-free survival	The time of randomization begins to tumor progression	3 years	No
Secondary	Quality of life (QOL)	Assess the quality of life of patients	3 years	No
Secondary	Phenotypic analysis of T cells	The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell	1 year	No