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

Primary Purpose

Esophageal Neoplasms, Neoplasms, Digestive System Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Paclitaxel
DC-CIK
Cisplatin
Sponsored by
Shenzhen Hornetcorn Bio-technology Company, LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Affiliated Tumor Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

DC-CIK

Chemotherapy

Arm Description

After accepting chemotherapy according to guidelines,patients will receive 3 cycles of autologous DC-CIK treatment.

After the Chemotherapy by Paclitaxel and Cisplatin, patients will just regularly follow up.

Outcomes

Primary Outcome Measures

Overall survival
The time of randomization begins to cause the death of any cause

Secondary Outcome Measures

Progress-free survival
The time of randomization begins to tumor progression
Quality of life (QOL)
Assess the quality of life of patients
Phenotypic analysis of T cells
The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell

Full Information

First Posted
December 28, 2015
Last Updated
May 23, 2016
Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02644863
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms, Neoplasms, Digestive System Neoplasms, Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DC-CIK
Arm Type
Experimental
Arm Description
After accepting chemotherapy according to guidelines,patients will receive 3 cycles of autologous DC-CIK treatment.
Arm Title
Chemotherapy
Arm Type
Sham Comparator
Arm Description
After the Chemotherapy by Paclitaxel and Cisplatin, patients will just regularly follow up.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
TP
Intervention Description
Paclitaxel 175mg/m2 IV over 2 hours,day 1; Repeat every 3 weeks;regimen for 3 cycles
Intervention Type
Biological
Intervention Name(s)
DC-CIK
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 30mg/m2 IV on 1-3 days, Repeat every 3 weeks;regimen for 3 cycles
Primary Outcome Measure Information:
Title
Overall survival
Description
The time of randomization begins to cause the death of any cause
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progress-free survival
Description
The time of randomization begins to tumor progression
Time Frame
3 years
Title
Quality of life (QOL)
Description
Assess the quality of life of patients
Time Frame
3 years
Title
Phenotypic analysis of T cells
Description
The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiyuan Wang, Professor
Email
wangzhiyuan@hornetcorn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiyuan Wang, Professor
Organizational Affiliation
Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center
Official's Role
Study Chair
Facility Information:
Facility Name
Affiliated Tumor Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyuan Wang
Email
wangzhiyuan@hornetcorn.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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