NCT02805829

Brief Summary

This trial is to evaluate the safety and effectiveness of activated and expanded in vitro autologous NK cells following trastuzumab treatment for patients Human Epidermal Receptor-2 overexpressing advanced 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
20

participants targeted

Target at below P25 for phase_1 gastric-cancer

Timeline
Completed

Started Jan 2017

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

First Submitted

Initial submission to the registry

June 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

3 years

First QC Date

June 15, 2016

Last Update Submit

June 20, 2016

Conditions

Gastric Cancer

Keywords

NK cellsTrastuzumab

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    2 years

Secondary Outcomes (1)

  • Number of Participants with tumor recurrence metastasis as a Measure of effectiveness

    2 years

Other Outcomes (1)

  • T cell subsets figures

    12 weeks

Study Arms (1)

Trastuzumab + NK cells

EXPERIMENTAL

On Cycle 1,day -2, patients will receive IV loading dose 8mg/Kg trastuzumab, followed by collection blood on day 0. After NK expansion and verification that the resulting NK cells meet release criteria, NK cells were washed and resuspended in isotonic sodium chloride for intravenous transfusion on day 14. NK cellular therapy conduct 2 cycles per year. The maintenance dose of trastuzumab monotherapy is 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks till to disease progress.

Drug: Trastuzumab + NK cells

Interventions

Trastuzumab + NK cellsDRUG

NK cellular therapy conduct 2 cycles per year. Herceptin initial dose of 8 mg/kg over 90 minutes IV infusion, followed by 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks till to disease progress.

Also known as: Herceptin
Trastuzumab + NK cells

Eligibility Criteria

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

You may qualify if:

  • Age equal to 18 years or older;
  • Patients with histologically confirmed HER2 positive advanced gastric cancer through immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH);
  • Normal marrow hematopoiesis function: Hemoglobin≥90g/L, White Blood Cell count≥4000/μL, absolute Neutrophil Cell count (ANC)≥1500/μL, Platelet≥100000/μL;
  • Normal important organ function: Total bilirubin≤1.5-fold institutional upper limit of normal (ULN), Aspartate aminotransferase and Alanine aminotransferase≤2.5-fold ULN, Creatinine clearance≥80mL/min;
  • Life expectancy≥6 months;
  • No other serious heart, lung, kidney dysfunction;
  • Quality of life (Karnofsky performance score)≥60;
  • Patient must be able to understand and be willing to sign a written informed consent document.

You may not qualify if:

  • Prior allergic reaction or hypersensitivity to cytokines (eg.Interleukin-2);
  • Patients with systemic or local infection requiring anti-infections treatment;
  • Patients currently treated with systemic immunosuppressive agents, including steroids;
  • Patients with active autoimmune disease or history of transplantation requiring steroid treatment;
  • Tested positive for HIV;
  • Pregnant or lactating women;
  • Patients with coagulation disorders;
  • Patients with important organ dysfunction, including cardiac, lung, liver;
  • Patients experiencing a cardiac events (acute coronary syndrome, myocardial infarction or ischemia) within the 3 months;
  • Any reason that, in the opinion of the investigator, contraindicates that the patient participates in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuzhou medical university

Xuzhou, Jiangsu, 221002, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Junnian Zheng, MD

    Xuzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junnian Zheng, MD

CONTACT

86-0516-83372010jnzheng@xzmc.edu.cn

Huizhong Li, MM

CONTACT

86-0516-85582635lhz@xzmc.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 20, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

June 22, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)