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

Launched by JIAN-KUN HU · Jun 8, 2018

Keywords

ClinConnect Summary

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 pro...

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Eligibility criteria

• 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.