NCT05466019招募中2 期
Toripalimab Combined With FLOT Regimen for Perioperative Treatment of PD-L1 Positive Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GEJ): a Prospective, Single-center Clinical Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR)
研究概览
简要总结
In this study, patients with PD-L1 positive locally advanced patients with resectable gastric cancer or gastroesophageal junction adenocarcinoma were invited to participate in the study.To evaluate the efficacy and safety of patients with PD-L1 positive gastric cancer or gastroesophageal junction adenocarcinoma (≥T3 and the number of lymph node metastasis ≥1, and No distant metastasis) using Toripalimab combined with docetaxel, oxaliplatin, fluorouracil, leucovorin (FLOT regimen) .
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of the patient;
- •18 years old <age <75 years old;
- •The researcher judged that he could comply with the study protocol;
- •Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert II-III);
- •Clinical stage at admission: ≥T3 with ≥1 lymph node metastasis and no distant metastasis (AJCC 8th)
- •Esophagogastroduodenoscopy must be performed
- •Diagnostic laparoscopy must be performed
- •Immunohistochemistry confirmed that the patient was PD-L1 positive (CPS≥1);
- •Preoperative ECOG [Using the ECOG scoring standard Zubrod-ECOG-WHO (ZPS, 5-point method) developed by the Eastern Cooperative Oncology Group (ECOG)] Physical State Score 0/1;
- •Preoperative ASA score I-III;
- •Expected survival ≥12 weeks;
- •The baseline blood routine and biochemical parameters of selected patients should meet the following criteria:
- •Hemoglobin ≥90g/ L, which can be met by blood transfusion;
- •Absolute neutrophil count ≥1.5×10^9/ L
- •Platelet count ≥100×10^9/ L
- •Aspartic acid or alanine aminotransferase ≤ 2.5 times the upper limit
- •Alkaline phosphatase ≤ 2.5 times normal upper limit (ULN),
- •Thyroid stimulating hormone (TSH) ≤1 times ULN (if abnormal, T3 and T4 levels should be investigated at the same time; if T3 and T4 levels are normal, they can be included in the group);
排除标准
- •Inestigators identified stage IV (metastatic) or unresectable gastric or gastroesophageal junction adenocarcinoma
- •Previous systemic treatment for gastric cancer
- •Have a history of allergy to any component of terriprizumab, oxaliplatin, capecitabine;
- •Received any of the following medical treatment:
- •A. Have received anti-PD-1 or anti-PD-L1 antibody therapy in the past; B. Have received any investigational drug treatment within 4 weeks before using the drug for the first time; C. Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; D. Receive the last dose of anti-cancer treatment (including radiotherapy) within 4 weeks before the first use of the study drug;; E. Receive systematic treatment with corticosteroids (> 10mg prednisone equivalent daily dose) or other immunosuppressants within 2 weeks prior to their first use of the study drug; F. Those who have been vaccinated with anti-tumor vaccines or the study drugs have been vaccinated with live vaccines within 4 weeks before the first administration; G. Those who have undergone major surgery or trauma within 4 weeks before using the study drug for the first time;
- •History of other malignant diseases within 5 years;
- •History of active autoimmune disease or autoimmune disease
- •The subject has cardiovascular clinical symptoms or disease that is not well controlled;
- •Severe infection 4 weeks prior to first use of study drug (CTCAE > Level 2)
- •A history of interstitial lung disease (except for radiation pneumonia not treated with Chinese hormone) or non-infectious pneumonia;
- •Patients with active pulmonary tuberculosis infection found by history or CT examination, or patients with active pulmonary tuberculosis infection history within 1 year before enrollment, or patients with active pulmonary tuberculosis interference history more than 1 year ago but without formal treatment;
- •Pregnant or lactating women;
- •Suffering from severe mental illness.
结局指标
主要结局
Pathological complete response (pCR)
时间窗: 3 months
次要结局
- overall survival (OS)(2 years)
- objective response rate (ORR)(3 months)
- index of tumor-infiltrating lymphocyte (sTIL) infiltration(3 months)
- event-free survival (EFS)(2 years)
- R0 Surgical conversion rate(3 months)
- major pathological response (MPR)(3 months)
- Incidence and severity of adverse events(6 months)
- type and number of intestinal flora(3 months)
- disease-free survival (DFS)(2 years)
研究者
Quan Wang
Professor
The First Hospital of Jilin University
研究点 (1)
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