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

NCT ID: NCT02644863

Last Updated: 2016-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Esophageal Neoplasms Neoplasms Digestive System Neoplasms Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DC-CIK

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

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

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

DC-CIK

Intervention Type BIOLOGICAL

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.

Cisplatin

Intervention Type DRUG

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

Chemotherapy

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

Group Type SHAM_COMPARATOR

Paclitaxel

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

Interventions

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Paclitaxel

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

Intervention Type DRUG

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.

Intervention Type BIOLOGICAL

Cisplatin

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

Intervention Type DRUG

Other Intervention Names

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TP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Shenzhen Hornetcorn Bio-technology Company, LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhiyuan Wang, Professor

Role: STUDY_CHAIR

Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center

Locations

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Affiliated Tumor Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhiyuan Wang, Professor

Role: CONTACT

Facility Contacts

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Zhiyuan Wang

Role: primary

Other Identifiers

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HYK-esophageal cancer

Identifier Type: -

Identifier Source: org_study_id

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