Clinical Trial of Intraperitoneal CAR-T Cells Infusion for the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- EpCAM CAR-T cells treatment related adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Hemoglobin≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L;
- •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;
- •Both patients and families totally understand the objectives and risks of the treatments and sign the informed consent.
排除标准
- •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;
- •Pregnant or lactation female;
- •Disagree to apply effective contraceptive methods in the period of treatment and one year after treatment;
- •Positive cytology examination alone.
研究组 & 干预措施
CAR-T cell and chemotherapy
Biological: CAR-T cells targeting EpCAM Chemotherapy: determined by medical Oncologist
干预措施: CAR-T cells targeting EpCAM (Biological)
CAR-T cell and chemotherapy
Biological: CAR-T cells targeting EpCAM Chemotherapy: determined by medical Oncologist
干预措施: Chemotherapy (Biological)
chemotherapy
Chemotherapy: determined by medical Oncologist
干预措施: Chemotherapy (Biological)
结局指标
主要结局
EpCAM CAR-T cells treatment related adverse events
时间窗: 4 weeks
Adverse events after receiving EpCAM CAR-T cells treatment, according to NCI-CTCAE v4.0.
次要结局
- Overall survival outcome(2 years)
- Metabolism kinetics of CAR-T cells(2 years)
- Progress free survival outcome(2 years)
研究者
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
West China Hospital