NCT05974059尚未招募2 期
Single-arm, Open-label, Single-center Phase II Clinical Study of Cadonilimab Combined With CapeOX Regimen in Perioperative Treatment of Resectable Locally Advanced Gastric Cancer
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年8月1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
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pathologic complete remission rate (PCR)
研究概览
简要总结
The efficacy and safety of combination with Cadonilimab and CapeOX Regimen for neoadjuvant treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.
详细描述
This study was a single arm, open-label, single-center clinical study to evaluate the efficacy and safety of combination with Cadonilimab and CapeOX Regimen for neoadjuvant treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.
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
- •Male or female, 18 years ≤ age ≤ 75 years;
- •ECOG score 0-1;
- •Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction.
- •c stageII, III(T1-4a/N+ M0, T3-4a/N-M0, AJCC 8th edition of gastric cancer cTNM stage) were performed according to enhanced CT/MRI examination (combined with ultrasonic gastroscopy and diagnostic laparoscopy if necessary).
- •The study site and the operator can complete radical dissection of D2 lymph nodes (the number of examined lymph nodes must be at least 15 to ensure the operation quality), and R0 resection;
- •Physical condition and organ function allow for larger abdominal surgery;
- •It has adequate organ and bone marrow functions and is defined as follows:
- •Blood routine test: absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count(PLT)≥100×109/L; Hemoglobin (HGB)≥9.0 g/dL; 2)Liver function: Total serum bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) is required for patients without liver metastasis. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5*ULN; 3)Renal function: creatinine clearance rate (Ccr)≥50 mL/min (calculated by Cockcroft/Gault formula); a Female: Ccr= (140-years) x Body Weight (kg) x 0.85 72 x serum creatinine (mg/dL) b Males: Ccr= (140-years) x Weight (kg) x 1.00 72 x serum creatinine (mg/dL) 4) Adequate coagulation, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the PT is within the intended range of the anticoagulant; 8 Left ventricular ejection fraction (LVEF)≥50% confirmed by echocardiography; 9 Agree and be able to comply with the protocol during the study; 10 Provide written informed consent prior to entering study screening and the patient is aware that she can withdraw from the study at any time during the study without loss; 11 Consent to provide blood and histological specimens
- •Exclusion Criteria
- •Complication of upper gastrointestinal tract obstruction/hemorrhage or digestive dysfunction or malabsorption syndrome;
- •Concomitant severe uncontrolled concurrent infection or other serious uncontrolled concomitant disease, moderate or severe renal injury;
- •Prior anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or immunotherapy;
- •Other malignancies (except basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or breast cancer) in the past 5 years;
- •Uncontrolled pleural effusion, pericardial effusion or ascites;
- •Serious cardiovascular disease such as symptomatic coronary heart disease, congestive heart failure ≥Grade II, uncontrolled arrhythmia, myocardial infarction within 12 months prior to enrollment;
- •Allergic reaction to the drugs used in this study;
- •Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrollment;
- •Patients receiving study medication within 4 weeks prior to enrollment (participating in other clinical trials);
- •Active autoimmune diseases;
- •Medical history of primary immunodeficiency;
- •Immunosuppressive medications were used within 4 weeks prior to the first dose of study treatment, excluding nasal spray, inhaled or other local corticosteroids or physiological doses of systemic corticosteroids (i.e. not more than 10 mg/day prednisone or equivalent dose of other corticosteroids), or the use of hormones to prevent contrast agent allergy;
- •Receiving an attenuated live vaccine within 4 weeks prior to the first dose of study treatment or scheduled for the duration of the study;
- •Known active tuberculosis;
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- •HIV antibody positive, active hepatitis B or hepatitis C (HBV, HCV);
- •Pregnant or lactating women;
排除标准
- 未提供
研究组 & 干预措施
Cadonilimab
Experimental
10 mg/kg, d1, Q3W;
干预措施: Oxaliplatin (Drug)
Cadonilimab
Experimental
10 mg/kg, d1, Q3W;
干预措施: Capecitabine (Drug)
Cadonilimab
Experimental
10 mg/kg, d1, Q3W;
干预措施: Cadonilimab (Drug)
结局指标
主要结局
Pathologic complete remission rate (PCR)
时间窗: up to 1 years
Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.
次要结局
- Disease Control Rate (DCR)(up to 3 years)
- Adverse Events（AEs）(up to 3 years)
- 3-year disease-free survival rate of 3year (DFS)(up to 3 years)
- Major pathological response rate (MPR)(up to 1 years)
- Objective response rate(ORR)(up to 3 years)
研究者
研究点 (1)
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