Suspended

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

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What is being tested

CAR-T cells targeting EpCAM

+ Chemotherapy

Biological
Who is being recruted

Digestive System Diseases+10

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

From 18 to 75 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 2018
See protocol details

Summary

Principal SponsorJian-Kun Hu
Study ContactJian-Kun Hu, M.D. Ph.D.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 30, 2018

Actual date on which the first participant was enrolled.

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.

Official TitleClinical Trial of Intraperitoneal CAR-T Cells Infusion for the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis
NCT03563326
Principal SponsorJian-Kun Hu
Study ContactJian-Kun Hu, M.D. Ph.D.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasm MetastasisNeoplasm SeedingNeoplasmsNeoplasms by SiteNeoplastic ProcessesPathologic ProcessesStomach DiseasesStomach NeoplasmsPathological Conditions, Signs and Symptoms

Criteria

7 inclusion criteria required to participate
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;

Show More Criteria

7 exclusion criteria prevent from participating
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;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Active Comparator
Chemotherapy: determined by medical Oncologist

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

West China Hospital, Sichuan University

Chengdu, ChinaOpen West China Hospital, Sichuan University in Google Maps
SuspendedOne Study Center