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

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

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

Study Overview

• Status: Unknown
• Conditions: Neoplasms; Digestive System Neoplasms; Esophageal Cancer; Esophageal Neoplasms
• Intervention / Treatment: Drug: Paclitaxel; Biological: DC-CIK; Drug: Cisplatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Affiliated Tumor Hospital of Guangzhou Medical University
      • Contact: Zhiyuan Wang; Email: wangzhiyuan@hornetcorn.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DC-CIK; After accepting chemotherapy according to guidelines,patients will receive 3 cycles of autologous DC-CIK treatment.	Drug: Paclitaxel; Paclitaxel 175mg/m2 IV over 2 hours,day 1; Repeat every 3 weeks;regimen for 3 cycles; Other Names: TP; 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
Sham Comparator: Chemotherapy; After the Chemotherapy by Paclitaxel and Cisplatin, patients will just regularly follow up.	Drug: Paclitaxel; Paclitaxel 175mg/m2 IV over 2 hours,day 1; Repeat every 3 weeks;regimen for 3 cycles; Other Names: TP; Drug: Cisplatin; Cisplatin 30mg/m2 IV on 1-3 days, Repeat every 3 weeks;regimen for 3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The time of randomization begins to cause the death of any cause	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progress-free survival	The time of randomization begins to tumor progression	3 years
Quality of life (QOL)	Assess the quality of life of patients	3 years
Phenotypic analysis of T cells	The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell	1 year

Collaborators and Investigators

• Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD
• Collaborators: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Investigators: Study Chair: Zhiyuan Wang, Professor, Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: December 28, 2015
• First Submitted That Met QC Criteria: December 31, 2015
• First Posted (Estimate): January 1, 2016

Study Record Updates

• Last Update Posted (Estimate): May 24, 2016
• Last Update Submitted That Met QC Criteria: May 23, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Cisplatin
• Other Study ID Numbers: HYK-esophageal cancer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided