NCT05101616暂停1 期
A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer: a Single-center, Open-label, Randomized Controlled Trial
Shanghai Minimally Invasive Surgery Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- major pathologic response rate
研究概览
简要总结
It is a single-center, open-lable, randomized controlled trial to prospectively investigate the effectiveness and safety of Camrelizumab combined with DOS regimen chemotherapy in neoadjuvant treatment of patients with locally advanced gastric cancer.
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
- 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
- •Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up;
- •Male or female patients between the ages of 18-75;
- •Patients diagnosed as gastric adenocarcinoma by histology or cytology;
- •Stage: Locally advanced stage (T3-4aN1-3M0);
- •Have not received other immunotherapy drugs or chemotherapy drugs in the past;
- •ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points;
- •Has sufficient organ and bone marrow function
排除标准
- •Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)];
- •A distant metastasis occurs;
- •Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
- •Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
- •Patients with any severe and/or uncontrollable disease；
- •Patients with gastrointestinal diseases with bleeding tendency (such as active gastrointestinal ulcers) or patients determined by the researcher to cause gastrointestinal bleeding, perforation or obstruction
- •Patients whose imaging shows that the tumor has invaded the tissues around important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
- •Received glucocorticosteroid or immunosuppressive therapy within 7 days before grouping;
- •Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers Or fracture
- •Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
- •People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
- •Participated in other anti-tumor drug clinical trials within four weeks;
- •According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study;
- •Female patients who are pregnant or breastfeeding;
- •Known hypersensitivity to any study drug.
研究组 & 干预措施
camrelizumab+chemotherapy
Experimental
neoadjuvant treatment with camrelizumab+chemotherapy
干预措施: camrelizumab+chemotherapy (Drug)
chemotherapy
Active Comparator
neoadjuvant treatment with chemotherapy
干预措施: Chemotherapy (Drug)
结局指标
主要结局
major pathologic response rate
时间窗: one month after surgery
complete or subtotal regression (\<10% residual tumor per tumor bed)
次要结局
- complete pathologic response rate(one month after surgery)
- Overall survival(3 years)
- perioperative complications(the time from the start of randomization to 3 months after surgery)
- Disease-free survival(3 years)
- R0 resection rate(one month after surgery)
研究者
研究点 (1)
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