NCT05524974尚未招募2 期
Clinical Efficacy of Carrelizumab, Apatinib Mesylate, Albumin Paclitaxel Combined With Oxaliplatin and S-1 in Neoadjuvant Treatment of Locally Advanced Gastric Cancer With Different Genotypes--A Prospective, Multi-center, Randomized Controlled Study
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2022年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
To evaluate the clinical efficacy of camrelizumab, apatinib Mesylate and nab-paclitaxel combined with oxplatin and S-1 in the neoadjuvant treatment of locally advanced gastric cancer with different genotypes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age from 18 to 75 years, all sex；
- •Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by histology or cytology；
- •CT/MRI,PET-CT or laparoscopic exploration were used to confirm the diagnosis of gastric cancer staging as cT2-4a and/or N+ and M0 before operation.；
- •measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.（CT scan of tumor lesion length≥10mm，CT scan short diameter of lymph node≥15mm，scan slice thickness 5mm）;
- •ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores;
- •the expected survival time is more than 12 weeks;
- •the main organ function is normal, which should meet the following criteria: （1）(1)blood routine examination standards should be met（no blood transfusion within 14 days）
- •WBC≥3×109/L
- •ANC≥1.5×109/L，
- •PLT≥100×109/L； （2）biochemical examination shall comply with the following criteria：
- •BIL <1.5normal upper limit（ULN），
- •ALT 和 AST<2.5ULN，GPT≤1.5×ULN；
- •serum Cr≤1ULN，creatinine clearance rate>60ml/min（Cockcroft-Gault formula）
- •women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug.；
- •No other clinical studies were conducted before and during the treatment； participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.
排除标准
- •Previous history of chemotherapy, radiotherapy, targeted drug therapy or immunotherapy
- •Patients with contraindications for surgical treatment and chemotherapy or whose physical condition and organ function do not allow for major abdominal surgery；
- •patients with metastasis；
- •Having any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Patients with vitiligo or cured childhood asthma/allergies who did not need any intervention in adulthood were excluded; Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone; Type 1 diabetes with stable doses of insulin；
- •A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation；
- •Accompanied by serious heart, lung, liver, kidney disease; Have nerve, mental disease; Jaundice or obstruction of the digestive tract with severe infection；
- •pregnant or lactating women；
- •The blood pressure of patients with hypertension cannot be reduced to the normal range by the antihypertensive drugs (systolic pressure >140 mmHg, diastolic pressure >90 mmHg)；
- •With Ⅰ magnitude of coronary heart disease, arrhythmia (including QTc protracted between male > 450 ms, women > 470 ms) and cardiac insufficiency；
- •Patients have a clear tendency with gastrointestinal bleeding, including the following situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena and hematemesis history in 2 months; and patients with fecal occult blood (+) and coagulation dysfunction (INR(international normalized ratio)>1.5, APTT(activated partial thromboplastin time)>1.5 ULN), with bleeding tendency;；
- •Subjects have failed to control good cardiovascular clinical symptoms or disease, including but not limited to: such as: (1) the NYHA class II heart failure or above (2) unstable angina pectoris (3) MI occurred within 1 year (4) have clinical significance of supraventricular or ventricular arrhythmias without clinical intervention on or after clinical intervention is still poorly controlled；
- •History of interstitial lung disease (except radiation pneumonia without hormone therapy), and history of non-infectious pneumonia；
- •Patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative >1.0g)；
- •A person who has previously been allergic to any component of the drug in this study； The researchers consider those who were not suitable for inclusion.
研究组 & 干预措施
Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes
Experimental
干预措施: Camrelizumab (Drug)
Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes
Experimental
干预措施: Oxaliplatin (Drug)
Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes
Experimental
干预措施: S1 (Drug)
Oxplatin and S-1 for Immune Genotypes
Active Comparator
干预措施: Oxaliplatin (Drug)
Oxplatin and S-1 for Immune Genotypes
Active Comparator
干预措施: S1 (Drug)
Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes
Experimental
干预措施: Oxaliplatin (Drug)
Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes
Experimental
干预措施: S1 (Drug)
Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes
Experimental
干预措施: Apatinib Mesylate (Drug)
Oxplatin and S-1 for Mesenchymal Genotypes
Active Comparator
干预措施: Oxaliplatin (Drug)
Oxplatin and S-1 for Mesenchymal Genotypes
Active Comparator
干预措施: S1 (Drug)
Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes
Experimental
干预措施: Oxaliplatin (Drug)
Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes
Experimental
干预措施: S1 (Drug)
Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes
Experimental
干预措施: Nab paclitaxel (Drug)
Oxplatin and S-1 for Classic Genotypes
Active Comparator
干预措施: Oxaliplatin (Drug)
Oxplatin and S-1 for Classic Genotypes
Active Comparator
干预措施: S1 (Drug)
Oxplatin and S-1 for Metabolic Genotypes
Active Comparator
干预措施: Oxaliplatin (Drug)
Oxplatin and S-1 for Metabolic Genotypes
Active Comparator
干预措施: S1 (Drug)
结局指标
主要结局
Objective response rate
时间窗: 4 months
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST
次要结局
- 30 days mortality rates(30 days)
- R0 resection rate(4 months)
- overall postoperative morbidity rates(30 days)
- Duration of postoperative hospital stay(30 days)
- The prediction performance of Exosome contents (including proteins, nucleic acids)(3 years)
- Disease control rate(4 months)
- 1-year and 3-year OS/DFS(1 and 3 years)
- adverse event(3 years)
研究者
Chang-Ming Huang, Prof.
Director of gastric surgery
Fujian Medical University
研究点 (1)
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