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

Phase 2

• Conditions: Esophageal Cancer; Digestive System Neoplasms; Esophageal Neoplasms; Neoplasms
• Interventions: Drug: Paclitaxel; Biological: DC-CIK; Drug: Cisplatin

• Registration Number: NCT02644863
• Lead Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD

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.

Study Timeline

• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-31
• Study First Posted: 2016-01-01
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-24
• Primary Completion: 2018-12
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Paclitaxel	After the Chemotherapy by Paclitaxel and Cisplatin, patients will just regularly follow up.
DC-CIK	DC-CIK	After accepting chemotherapy according to guidelines,patients will receive 3 cycles of autologous DC-CIK treatment.
Chemotherapy	Cisplatin	After the Chemotherapy by Paclitaxel and Cisplatin, patients will just regularly follow up.
DC-CIK	Paclitaxel	After accepting chemotherapy according to guidelines,patients will receive 3 cycles of autologous DC-CIK treatment.
DC-CIK	Cisplatin	After accepting chemotherapy according to guidelines,patients will receive 3 cycles of autologous DC-CIK treatment.

Primary Outcome Measures

Name	Time	Method
Overall survival	3 years	The time of randomization begins to cause the death of any cause

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Affiliated Tumor Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China