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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02644863

Enrollment

Registered

2016-01-01

Start date

2015-12-31

Completion date

2019-05-31

Last updated

2016-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Neoplasms, Neoplasms, Digestive System Neoplasms, Esophageal Cancer

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.

Interventions

DRUGPaclitaxel

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

BIOLOGICALDC-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.

DRUGCisplatin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactZhiyuan Wang, Professor

wangzhiyuan@hornetcorn.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026