NCT03563326

Brief Summary

To investigate the safety and efficacy of intraperitoneal infusion of EpCAM CAR-T cell in advanced gastric cancer with peritoneal metastasis by a prospective nonrandomized controlled trial.

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 P50-P75 for phase_1

Timeline
Completed

Started Aug 2018

Longer than P75 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

First Submitted

Initial submission to the registry

May 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

May 5, 2018

Last Update Submit

September 14, 2018

Conditions

Neoplasm, StomachMetastases, NeoplasmNeoplasm Seeding

Keywords

Epithelial Cell Adhesion MoleculeChimeric Antigen Receptor-modified T cellGastric carcinomaPeritoneal metastasis

Outcome Measures

Primary Outcomes (1)

  • EpCAM CAR-T cells treatment related adverse events

    Adverse events after receiving EpCAM CAR-T cells treatment, according to NCI-CTCAE v4.0.

    4 weeks

Secondary Outcomes (3)

  • Overall survival outcome

    2 years

  • Metabolism kinetics of CAR-T cells

    2 years

  • Progress free survival outcome

    2 years

Study Arms (2)

CAR-T cell and chemotherapy

EXPERIMENTAL

Biological: CAR-T cells targeting EpCAM Chemotherapy: determined by medical Oncologist

Biological: CAR-T cells targeting EpCAMBiological: Chemotherapy

chemotherapy

ACTIVE COMPARATOR

Chemotherapy: determined by medical Oncologist

Biological: Chemotherapy

Interventions

CAR-T cells targeting EpCAMBIOLOGICAL

Biological: CAR-T cells targeting EpCAM

CAR-T cell and chemotherapy
ChemotherapyBIOLOGICAL

Chemotherapy: determined by medical Oncologist

CAR-T cell and chemotherapychemotherapy

Eligibility Criteria

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

You may qualify if:

  • Patients with EpCAM positive gastric cancer who have peritoneal metastasis at first visit; Patients with highly suspected or previous proven peritoneal metastasis by biopsy, CT, digital rectal examination, etc. who failed to the routine therapies like chemotherapy;
  • Age between 18 and 75;
  • Estimated survival time is longer than 3 months;
  • Eastern Cooperative Oncology Group (ECOG）scores 0-2;
  • Hemoglobin≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L;
  • Negative pregnancy test for child-bearing period; both male and female patients should agree to apply effective contraceptive methods in the period of treatment and one year after treatment;
  • Both patients and families totally understand the objectives and risks of the treatments and sign the informed consent.

You may not qualify if:

  • Comorbidity with other diseases treated by immunosuppressive drugs or steroids therapy systematically;
  • Uncontrolled active infection;
  • HIV positive;
  • Active hepatic B or C virus infection, active tuberculosis;
  • Pregnant or lactation female;
  • Disagree to apply effective contraceptive methods in the period of treatment and one year after treatment;
  • Positive cytology examination alone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasm MetastasisNeoplasm SeedingColorectal Cancer, Hereditary Nonpolyposis, Type 8

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jian-Kun Hu, M.D. Ph.D.

    West China Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Kun Hu, M.D. Ph.D.

CONTACT

02885422878hujkwch@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice director of Gastrointestinal Surgery department, West China Hospital; Director of Institute of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital

Study Record Dates

First Submitted

May 5, 2018

First Posted

June 20, 2018

Study Start

August 30, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2022

Last Updated

September 17, 2018

Record last verified: 2018-09

Locations

CN(1)