NCT02644863

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 24, 2016

Status Verified

December 1, 2015

Enrollment Period

3 years

First QC Date

December 28, 2015

Last Update Submit

May 23, 2016

Conditions

Esophageal NeoplasmsNeoplasmsDigestive System NeoplasmsEsophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

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

    3 years

Secondary Outcomes (3)

  • Progress-free survival

    3 years

  • Quality of life (QOL)

    3 years

  • Phenotypic analysis of T cells

    1 year

Study Arms (2)

DC-CIK

EXPERIMENTAL

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

Drug: PaclitaxelBiological: DC-CIKDrug: Cisplatin

Chemotherapy

SHAM COMPARATOR

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

Drug: PaclitaxelDrug: Cisplatin

Interventions

PaclitaxelDRUG

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

Also known as: TP
ChemotherapyDC-CIK
DC-CIKBIOLOGICAL

Antigen-sensitized DC-CIK 8Ă—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.

DC-CIK
CisplatinDRUG

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

ChemotherapyDC-CIK

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Tumor Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Esophageal NeoplasmsNeoplasmsDigestive System Neoplasms

Interventions

PaclitaxelCisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Zhiyuan Wang, Professor

    Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center

    STUDY CHAIR

Central Study Contacts

Zhiyuan Wang, Professor

CONTACT

wangzhiyuan@hornetcorn.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 1, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2018

Study Completion

May 1, 2019

Last Updated

May 24, 2016

Record last verified: 2015-12

Locations

CN(1)