NCT06496789招募中2 期
Neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer: a Single-arm Phase 2 Trial
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年5月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- PCR
研究概览
简要总结
evaluate efficacy and safety of neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer
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
- •histologically documented adenocarcinoma of Gastric or Gastroesophageal Junction.
- •clinically diagnosed stage T3-4aN+M0 according to ultrasound endoscopy or enhanced CT/MRI scan.
- •Male or female. Age ≥ 18 years and ≤75 years.
- •surgeons participating in this study consider the lesion a resectable one.
- •Physical condition and adequate organ function to ensure the success of abdominal surgery.
- •Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
- •Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN . ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.
- •Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min.
- •Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN.
- •No serious concomitant disease that will threaten the survival of patients to less than 5 years.
- •Written (signed) informed consent.
- •Good compliance with the study procedures, including lab and auxiliary examination and treatment.
- •Female patients should not be pregnant or breast feeding.
- •PD-L1 assessment
排除标准
- •patients with distant metastasis or unresectable primary lesion.
- •patients with T1, T2 lesion according to CT/MRI or ultrasound endoscopy.
- •history of chemo, radiation, immune therapy or radical resection for the GC/GEJ.
- •patients with active autoimmune disease or history of refractory autoimmune disease.
- •patients with active malignant tumor in recent 2 years, except the tumor studied in this research or cured locally tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ.
- •uncontrollable pleural effusion, pericardial effusion, or ascites in 2 weeks before recruitment.
- •patients who have digestive tract bleeding in 2 weeks before recruitment or with high risk of bleeding.
- •perforation / fistula of GI tract in 6 months before recruitment.
- •patients with upper GI tract obstruction or functional abnormality or malabsorption syndrome, which can affect absorption of S-
- •losing over 20% body weight in 2 months before recruitment.
- •pulmonary disease history: interstitial pulmonary disease, non-infective pneumonitis, pulmonary fibrosis, acute pulmonary disease.
- •uncontrollable systemic diseases, including diabetes, hypertension, etc.
- •severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB or HIV, etc.
- •patients with untreated chronic hepatitis B or HBV DNA over 500 IU/ml or positive HCV RNA.
- •patients with any cardiovascular risk factors below:
- •cardiac chest pain occurring in 28 days before recruitment, defined as moderate pain that limits daily activity.
- •pulmonary embolism with symptoms occurring in 28 days before recruitment.
- •acute myocardial infarction occurring in 6 months before recruitment.
- •any history of heart failure reaching grade 3/4 of NYHA in 6 months before recruitment.
- •ventricular arrhythmias of Grade 2 or grater in 6 months before recruitment, or accompanied by supraventricular tachyarrhythmias requiring medical treatment.
- •cerebrovascular accident within 6 months before recruitment.
- •patients with peripheral neuropathy NCI CTC AE grade 1, except those with only deep tendon reflex disappearing.
- •moderate or severe renal injury [creatinine clearance rate≤50 ml/min (according to Cockroft & Gault equation)], or Scr>1.5 x ULN.
- •dipyrimidine dehydrogenase (DPD) deficiency.
- •allergic to any drug in this study.
- •history of allogeneic stem cell transplantation or organ transplantation.
- •use of steroids (dosage>10mg/d prednisone) or other systemic immune suppressive therapy in 14 days before recruitment, except patients treated with regimens below: a. steroids for hormone replacement (dosage>10mg/d prednisone); b. steroids for local application with little systemic absorption; c. short -term (≤ 7 days) steroids for preventing allergy or vomiting.
- •vaccinated with live vaccine in 4 weeks before recruitment.
- •receiving immune (interleukin, interferon, thymin) treatment or treatment of other trials in 28 days before recruitment.
- •receiving palliative radiation in 14 days before recruitment.
- •history of anti PD-1, PD-L1, PD-L2 or any other specific T cell costimulation or checkpoint pathway targeted treatment.
- •receiving operation in 28 days before recruitment, only if the operation is a minimally invasive one e.g. PICC.
- •for patients with uncontrolled epilepsy, CNS diseases or history of mental disorder, researchers should evaluate whether their diseases will impede their signing of informed consent or compliance of treatment.
研究组 & 干预措施
Neoadjuvant chemotherapy
Experimental
干预措施: Serplulimab+SOX (Drug)
结局指标
主要结局
PCR
时间窗: 3 months after the last subject participating in
Pathological complete regression rate
次要结局
未报告次要终点
研究者
研究点 (1)
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