A Prospective Study of Intraperitoneal and Intravenous Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- R0-resection rate
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous nab-paclitaxel plus Camrelizumab and S-1 conversion therapy for gastric cancer with positive exfoliative cancer cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •None previous chemotherapy, radiotherapy and other antitumor therapy;
- •Age:18 to 70 years old;
- •Man or female (except pregnant and lactating women);
- •Confirmed to gastric adenocarcinoma and HER2-negative;
- •Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive;
- •Blood cell count has to meet the following certeria:
- •WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L;
- •Liver/kidney function has to meet the following certeria:
- •ALT and AST≤2.5×ULN TBIL<1.5×ULN； Serum creatinine ≤1.5×ULN;
- •Left ventricular ejection fraction (LVEF) ≥50%;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Participants were willing to join in this study, good adherence and written informed consent.
排除标准
- •Subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose);
- •The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
- •Patients with other malignant tumors within 5 years;
- •Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA ≥1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study;
- •Distant metastasis;
- •It has serious or uncontrolled medical diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on);
- •History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- •Patients with severe or uncontrollable mental illness;
- •It have serious harm to the patient's safety or affect the patients who have completed the research.
- •The researchers think inappropriate.
研究组 & 干预措施
Experimental
Camrelizumab: 200mg，iv，30min, q3w, 4 cycles. Nab-Paclitaxel: intraperitoneal nab-paclitaxel 80 mg/m2 and intravenous nab-paclitaxel 180 mg/m2 on days 1, q3w, 4 cycles.
S-1：According to the body surface area, BSA <1.25m2，40mg bid; 1.25m2≤BSA≤1.5m2，50mg bid; BSA >1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week, q3w, 4 cycles.
For patients who were operable, the original regimen was continued for 4 cycles of adjuvant treatment after operation, followed by maintenance of carrelizumab monotherapy to 1 year.
Inoperable patients were selected for follow-up treatment according to guidelines recommended by the investigator.
干预措施: Camrelizumab Nab-Paclitaxel S-1 (Drug)
结局指标
主要结局
R0-resection rate
时间窗: within 3 weeks after surgery
There was no residual by the microscope
Conversion to negative rate
时间窗: within 3 weeks after surgery
Exfoliative cytology positive gastric cancer conversion to negative rate
次要结局
- Overall survival (OS)(3years)
- Objective response rate (ORR)(tumor assessment every 6 weeks since the treatment began，up to 3years)
- Tumor regression grade (TRG)(within 3 weeks after surgery)
- Progression free survival (PFS)(3years)
- Disease control rate (DCR)(tumor assessment every 6 weeks since the treatment began，up to 3years)
- Adverse events(3 years)
研究者
Qun Zhao
Principal Investigator
Hebei Medical University