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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-30

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neoplasm, Stomach Metastases, Neoplasm Neoplasm Seeding

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CAR-T cell and chemotherapy

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

Group Type EXPERIMENTAL

CAR-T cells targeting EpCAM

Intervention Type BIOLOGICAL

Biological: CAR-T cells targeting EpCAM

Chemotherapy

Intervention Type BIOLOGICAL

Chemotherapy: determined by medical Oncologist

chemotherapy

Chemotherapy: determined by medical Oncologist

Group Type ACTIVE_COMPARATOR

Chemotherapy

Intervention Type BIOLOGICAL

Chemotherapy: determined by medical Oncologist

Interventions

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CAR-T cells targeting EpCAM

Biological: CAR-T cells targeting EpCAM

Intervention Type BIOLOGICAL

Chemotherapy

Chemotherapy: determined by medical Oncologist

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jian-Kun Hu

Vice director of Gastrointestinal Surgery department, West China Hospital; Director of Institute of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital

Responsibility Role SPONSOR_INVESTIGATOR