NCT02215837

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with autologous tumor Lysate-pulsed dendritic with cytokine-induced killer cell (Ag-D-CIK) for gastric 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
40

participants targeted

Target at P25-P50 for phase_2 gastric-cancer

Timeline
Completed

Started Aug 2014

Typical duration for phase_2 gastric-cancer

Geographic Reach
1 country

2 active sites

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

August 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 24, 2016

Status Verified

November 1, 2015

Enrollment Period

3.8 years

First QC Date

August 12, 2014

Last Update Submit

May 23, 2016

Conditions

Gastric CancerNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsGastrointestinal Diseases

Keywords

Gastric cancerD-CIKAutologous tumor lysate

Outcome Measures

Primary Outcomes (1)

  • Progress-free survival

    3 years

Secondary Outcomes (4)

  • Overall survival

    3 years

  • Quality of life (QOL)

    3 years

  • Phenotypic analysis of T cells

    1 years

  • Severity of adverse events

    1 years

Study Arms (2)

Chemotherapy

SHAM COMPARATOR

After accepting chemotherapy according to NCCN guidelines, patients will just regularly follow up.

Drug: Chemotherapy

Ag-D-CIK

EXPERIMENTAL

After accepting chemotherapy according to NCCN guidelines,patients will receive 3 cycles of autologous tumor lysate pulsed D-CIK treatment.

Drug: ChemotherapyBiological: Ag-D-CIK

Interventions

ChemotherapyDRUG

Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.

Also known as: FOLFOX
Ag-D-CIKChemotherapy
Ag-D-CIKBIOLOGICAL

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.

Ag-D-CIK

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who can accept curative operations
  • \~80 years old
  • Histologically confirmed with gastric cancer at stage Ⅰ\~Ⅲ
  • Patients who can accept radical gastrectomy;
  • Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.

You may not qualify if:

  • Hemoglobin\<8.0 g/dL,White blood cell \<3 x 10\^9/L;Platelet count \<75 x 10\^9/L; ALT, AST, 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
  • Patients who are suffering from serious organ dysfunction
  • Patients who are suffering from other cancer
  • Other situations that the researchers considered unsuitable for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center

Guangzhou, Guangdong, 510000, China

Location

Jingzhou Central Hospital Immunotherapy center

Jingzhou, Hubei, 434020, China

Location

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsGastrointestinal Diseases

Interventions

Drug TherapyFolfox protocol

Condition Hierarchy (Ancestors)

Neoplasms by SiteDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Hai Y Liu, Professor

    Affiliated Tumor Hospital of Guangzhou Medical University immunotherapy center

    PRINCIPAL INVESTIGATOR

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

August 12, 2014

First Posted

August 13, 2014

Study Start

August 1, 2014

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

May 24, 2016

Record last verified: 2015-11

Locations

CN(2)