NCT02317471

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of 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
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2014

Typical duration for phase_1

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

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 16, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 6, 2016

Status Verified

June 1, 2016

Enrollment Period

3.1 years

First QC Date

December 10, 2014

Last Update Submit

June 2, 2016

Conditions

Gastric Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Disease free survival

    2 years

  • Number of participants with adverse events related to gp96 immunotherapy

    A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason. And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 3.0 criteria.

    participants will be followed from the day of the first vaccination to the 30th day after the last vaccination.

Secondary Outcomes (2)

  • Changes in antigen specific T cells

    within 3 days before the first vaccination and within 3 days after the 10th vaccination

  • Overall survival

    3 years

Study Arms (2)

gp96 group

EXPERIMENTAL

autologous gp96 vaccination + basal treatment for gastric cancer

Biological: autologous gp96 vaccinationDrug: Oxaliplatin+S-1

control group

OTHER

Oxaliplatin+S-1

Drug: Oxaliplatin+S-1

Interventions

autologous gp96 vaccinationBIOLOGICAL

Vaccination of gp96 derived from autologous tumor tissue. Treatment will be started between 3-6 weeks after the surgery. gp96 of 25ug in 1mL normal saline s.c. on days 1 of each cycle, up to a maximum of 10 doses (1 cycle= 7 days). 200-400mg cyclophosphamide i.v. 1-3 days before each gp96 infusion.

gp96 group
Oxaliplatin+S-1DRUG

Treatment will be start at the 5th week after the surgery. S-1: 40\~60mg bid，d1\~14 q3W; oxaliplatin:130mg/m2，iv drip for 2h，d1,q3W 6 cycles.

Also known as: Oxaliplatin(Sanofi-aventis), S-1(Taiho)
control groupgp96 group

Eligibility Criteria

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

You may qualify if:

  • Disease characteristics: Histologically confirmed gastric carcinoma: clinical stage III (according to the Japanese gastric cancer classification), must have undergone radical resection
  • Able to read and understand the informed consent document, must sign the informed consent
  • Age: 18 to 75 years old
  • Availability of at least 0.5 g tumor sample
  • ECOG ≤1；life expectancy \>=12 weeks, able to comply with study-related procedures
  • Adequate bone marrow function including the absence of lymphopenia (ANC \> 1,500/ mm3; Hemoglobin \> 10g/dL ; platelet count \>100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase \[AST\], alanine amino transferase \[ALT\] \<2.5 times institutional upper limit of normals \[IULNs\] and bilirubin (total) \<1.5 times IULN), and adequate renal function (BUN and creatinine \<1.5 times IULNs)
  • Normal heart function
  • NOT participate in ANY other clinical trials within 4 weeks prior to vaccination.

You may not qualify if:

  • Unable to get the informed consent
  • Female patients who are pregnant or breastfeeding
  • Progression prior to treatment as determined by the principal investigator
  • Transplant recipient
  • Patients currently diagnosed with Human Immunodeficiency Virus or other active uncontrolled infection
  • Unstable or severe intercurrent medical conditions
  • Patient with allergic constitution
  • Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Lin Chen, MD

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Peng, MD

CONTACT

086-10-66938028zihpeng@sina.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the general surgery department

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 16, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

June 6, 2016

Record last verified: 2016-06

Locations

CN(1)