NCT03410732

Brief Summary

Study objectives are to investigate the efficacy and safety of activated autologous dendritic cells (DCs) in treatment of gastric cancer. DCs are activated by the proteins from autologous tumor cell membrane and cytokines in vitro. The efficacy endpoints include objective response, immune-cell response, recurrent rate after a radical surgery, progression-free survival and overall survival, and the safety endpoints include adverse events, laboratory tests, ECG, ECOG-PT, etc.

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
120

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started Jul 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

Study Start

First participant enrolled

July 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

January 16, 2018

Last Update Submit

January 24, 2018

Conditions

Gastric Cancer

Keywords

dendritic cellimmunotherapytumor cell membrane proteins

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    Time to progression/death or censored time

    3 years

Secondary Outcomes (4)

  • recurrent rate

    3 years

  • overall survival rate

    5 years

  • immune-cells response

    3 months

  • Adverse event rate

    3 months

Study Arms (2)

Radical surgery plus activated DCs

EXPERIMENTAL

In 21 days after a radical surgery, activated DCs are iv infused

Biological: activated DCsProcedure: radical surgery only

Radical surgery only

ACTIVE COMPARATOR

Radical surgery only group as a control group

Procedure: radical surgery only

Interventions

activated DCsBIOLOGICAL

autologous dendritic cells are collected and enriched from 50 ml of peripheral blood, then activated by autologous tumor cell membrane proteins. Then the activated DCs are iv infused in 21 days after a radical surgery.

Also known as: activated DCs by autologous tumor cell membrane proteins
Radical surgery plus activated DCs
radical surgery onlyPROCEDURE

Only radical surgery is given to the control group

Radical surgery onlyRadical surgery plus activated DCs

Eligibility Criteria

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

You may qualify if:

  • Written informed consent given before any trial-specific procedure is initiated
  • Male or female, at least 18 years of age at the time of informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Life expectancy \>3 months assessed during Screening
  • Documented (histologically- or cytologically-proven) gastric cancer that is can be radially removed

You may not qualify if:

  • Non-healing wounds on any part of the body
  • Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 1 month prior to surgery, unless adequately treated and stable
  • Active uncontrolled bleeding or a known bleeding diathesis
  • Significant cardiovascular disease or condition, including:
  • Congestive heart failure currently requiring therapy
  • Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) functional criteria (25)
  • Need for antiarrhythmic medical therapy for a ventricular arrhythmia
  • Severe conduction disturbance (e.g., 3rd degree heart block)
  • Unstable angina pectoris (last episode at least 6 months prior to surgery)
  • Uncontrolled hypertension (per the Investigator's discretion)
  • Myocardial infarction within 6 months prior to C1/D1
  • Abnormal hematologic, renal or hepatic function as defined by the following criteria:
  • Absolute neutrophil count (ANC) \<1.5 ×109/L (1500/mm3)
  • Hemoglobin ≤9 g/dL
  • Platelet count \<75 ×109/L (75,000/mm3)
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Yumin Li

    Lanzhou University Second Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yumin Li, MD, PhD

CONTACT

+8613893615421liym@lzu.edu.cn

Gui Gao, MD, PhD

CONTACT

+86-931-8942281Scottgao1110@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph D

Study Record Dates

First Submitted

January 16, 2018

First Posted

January 25, 2018

Study Start

July 1, 2017

Primary Completion

July 1, 2020

Study Completion

December 1, 2020

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

CN(1)