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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Biological: CAR-T cells targeting EpCAM
Chemotherapy: determined by medical Oncologist
West China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGEpCAM CAR-T cells treatment related adverse events
Adverse events after receiving EpCAM CAR-T cells treatment, according to NCI-CTCAE v4.0.
Time frame: 4 weeks
Overall survival outcome
2-year overall survival rate
Time frame: 2 years
Metabolism kinetics of CAR-T cells
The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry.
Time frame: 2 years
Progress free survival outcome
2-year progress free survival
Time frame: 2 years
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