A Real-world Study of Camrelizumab Alone or in Combination With Apatinib/Chemotherapy for Advanced Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
The purpose of this observational study is to evaluate the safety and efficacy of camrelizumab and apatinib in patients with advanced gastric cancer under real-life conditions, particularly in various subgroups of gastric cancer patients, with a view to providing information about the treatment modalities and efficacy of the treatment in real-life gastric cancer patients and to explore the possible predictive biomarkers of prognosis.Patients, who had both decided to be treated with camrelizumab or apatinib prior to enrollment, were entered into one of the following three cohorts at the discretion of the investigator, based on their disease stage and prior treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 ≥18 years old, both male and female;
- •patients with advanced gastric cancer diagnosed by pathology or histology and progressed or recurred after 6 months of adjuvant therapy can also be considered for enrollment;
- •Have at least one measurable lesion on imaging (RECIST 1.1 criteria), the spiral CT or MR target lesion should be ≥10 mm and lymph node ≥15 mm;
- •The investigator determines that the patient is amenable to treatment with karelizumab or apatinib;
- •Voluntary enrollment; good compliance and willingness to cooperate with follow-up.
排除标准
- •Pregnant or lactating women;
- •Previous use of other immunotherapy drugs (e.g. PD-1 monoclonal antibody, PD-L1 monoclonal antibody, CTLA4 monoclonal antibody, etc.);
- •Prior use of other anti-angiogenic therapeutic agents (e.g., apatinib, etc.);
- •Patients who, in the judgment of the investigator, are not suitable for inclusion.
研究组 & 干预措施
cohort 1
First-line
干预措施: Camrelizumab (Drug)
cohort 1
First-line
干预措施: apatinib (Drug)
cohort 1
First-line
干预措施: chemotherapy (Drug)
cohort 2
Second-line
干预措施: Camrelizumab (Drug)
cohort 2
Second-line
干预措施: apatinib (Drug)
cohort 2
Second-line
干预措施: chemotherapy (Drug)
cohort 3
Third-line and above
干预措施: Camrelizumab (Drug)
cohort 3
Third-line and above
干预措施: apatinib (Drug)
cohort 3
Third-line and above
干预措施: chemotherapy (Drug)
结局指标
主要结局
Objective response rate
时间窗: 24 months
The percentage of subjects achieving complete or partial response in a real-world clinical setting.
次要结局
- Overall survival(24 months)
- Disease control rate(24 months)
- Progression free survival(24 months)