Intraperitoneal Infusion of EpCAM CAR-T Cell in Advanced Gastric Cancer With Peritoneal Metastasis (WCH-GC-CART)

September 14, 2018 updated by: Jian-Kun Hu

Clinical Trial of Intraperitoneal CAR-T Cells Infusion for the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chimeric antigen receptor modified T (CAR-T) cells have the capability in targeting and recognizing tumor antigen, and can specifically recognize, bind and kill tumor cells with positive antigen. Through local drug delivery, CAR-T cells have successfully achieved remarkable effect to treat solid tumors. Gastric cancer is one of the most frequent malignant tumors with high mortality, especially in China. Peritoneal metastasis is one of the common routes of metastasis. Once peritoneal metastasis occurred, patients should be categorized as clinical pathological stage IV with extremely poor prognosis, and the effect of routine treatments would be unsatisfactory. Epithelial cell adhesion molecule (EpCAM) is highly expressed in gastric cancer cells and closely associated with the poor prognosis of patients. In our previous pre-clinical research researches, the investigators have obtained CAR-T cells targeting EpCAM (EpCAM CAR-T), and finished the preparations of cells which could be used in clinical practice. Based on our previous works, the investigators aim to investigate the safety and efficacy of peritoneal infusion of EpCAM CAR-T cell in advanced gastric cancer with peritoneal metastasis by a prospective nonrandomized controlled trial. The results of this clinical trial are expected to provide the new treatment strategy for gastric cancer patients with peritoneal metastasis.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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;
  2. Age between 18 and 75;
  3. Estimated survival time is longer than 3 months;
  4. Eastern Cooperative Oncology Group (ECOG）scores 0-2;
  5. Hemoglobin≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L;
  6. 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;
  7. Both patients and families totally understand the objectives and risks of the treatments and sign the informed consent.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAR-T cell and chemotherapy
Biological: CAR-T cells targeting EpCAM Chemotherapy: determined by medical Oncologist
Biological: CAR-T cells targeting EpCAM
Biological: CAR-T cells targeting EpCAM
Biological: Chemotherapy
Chemotherapy: determined by medical Oncologist
Active Comparator: chemotherapy
Chemotherapy: determined by medical Oncologist
Biological: Chemotherapy
Chemotherapy: determined by medical Oncologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EpCAM CAR-T cells treatment related adverse events
Time Frame: 4 weeks
Adverse events after receiving EpCAM CAR-T cells treatment, according to NCI-CTCAE v4.0.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival outcome
Time Frame: 2 years
2-year overall survival rate
2 years
Metabolism kinetics of CAR-T cells
Time Frame: 2 years
The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry.
2 years
Progress free survival outcome
Time Frame: 2 years
2-year progress free survival
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jian-Kun Hu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 5, 2018

First Submitted That Met QC Criteria

June 8, 2018

First Posted (Actual)

June 20, 2018

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 14, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCH-GC-CART

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

pending

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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