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

Phase 1

• Conditions: Neoplasm, Stomach; Neoplasm Seeding; Metastases, Neoplasm
• Interventions: Biological: CAR-T cells targeting EpCAM; Biological: Chemotherapy

• Registration Number: NCT03563326
• Lead Sponsor: Jian-Kun Hu

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.

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 Timeline

• Study First Submitted: 2018-05-05
• Study First Submitted QC: 2018-06-08
• Study First Posted: 2018-06-20
• Study Start: 2018-08-30
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-14
• Last Update Posted: 2018-09-17
• Primary Completion: 2019-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAR-T cell and chemotherapy	CAR-T cells targeting EpCAM	Biological: CAR-T cells targeting EpCAM Chemotherapy: determined by medical Oncologist
CAR-T cell and chemotherapy	Chemotherapy	Biological: CAR-T cells targeting EpCAM Chemotherapy: determined by medical Oncologist
chemotherapy	Chemotherapy	Chemotherapy: determined by medical Oncologist

Primary Outcome Measures

Name	Time	Method
EpCAM CAR-T cells treatment related adverse events	4 weeks	Adverse events after receiving EpCAM CAR-T cells treatment, according to NCI-CTCAE v4.0.

Secondary Outcome Measures

Name	Time	Method
Overall survival outcome	2 years	2-year overall survival rate
Metabolism kinetics of CAR-T cells	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.
Progress free survival outcome	2 years	2-year progress free survival

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China