NCT06727981招募中不适用
Prospective Cohort Study on the Efficacy, Adverse Effects, and Biomarkers of First-Line/Neoadjuvant Therapy With Immune Checkpoint Inhibitors Combined With Chemotherapy in Advanced Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This prospective observational study aims to evaluate the efficacy and safety of immune checkpoint inhibitors as first-line and neoadjuvant therapy for advanced gastric cancer, while also investigating relevant biomarkers to better understand their role in immunotherapy outcomes
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years old or above
- •Patients with advanced gastric cancer or locally advanced gastric cancer
- •Have not received any previous anti-tumor therapy
- •Patients expected to receive immunotherapy for first-line or neoadjuvant therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Adequate organ function
排除标准
- •Patients with contraindications to immunotherapy
- •Have received anti-tumor treatments such as immunotherapy and chemotherapy
- •Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases
- •Severe chronic or active infection requires systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection. Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment
- •History of allogeneic stem cell transplantation or organ transplantation
研究组 & 干预措施
Chemotherapy
干预措施: Chemotherapy (Drug)
ICI plus chemotherapy
干预措施: ICI plus Chemothearpy (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 12 months after the last subject participating in
The time from the starting date of study drug to death
次要结局
- Disease Control Rate (DCR) as assessed by RECIST1.1(6 months after the last subject participating in)
- Duration of response (DOR) as assessed by RECIST1.1(12 months after the last subject participating in)
- Number of participants with treatment-related adverse events as assessed by CTCAE5.0(12 months after the last subject participating in)
- Progression-free survival (PFS) as assessed by RECIST1.1(12 months after the last subject participating in)
- Objective remission rate (ORR) as assessed by RECIST1.1(3 months after the last subject participating in)
- Disease-free survival (DFS) as assessed by RECIST1.1(36 months after the last subject participating in)
- Major pathological response (MPR)(3 months after the last subject participating in)
研究者
Lian Liu, MD, PHD
Professor, Chief Physician
Qilu Hospital of Shandong University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Prospective cohort study on immunogenicity, safety and efficacy of seasonal influenza vaccination to healthy adults who received non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccination one year agoJPRN-UMIN000004631ational Hospital Organization, Tokyo National Hospital100
已完成
不适用
A prospective observational study of immune-checkpoint inhibitor (Nivolumab) treatment in patients with non-small cell lung canceron-small cell lung cancerJPRN-UMIN000021600Kitasato University School of Medicine52
招募中
2 期
Immune Checkpoint Inhibitors Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLCNSCLC Associated With Leptomeningeal MetastasesNCT06132698West China Hospital17
已完成
不适用
Vaccine Immune Recovery After LeukemiaAcute Lymphoblastic Leukemia, PediatricNCT05622682Children's Hospital of Philadelphia89
已完成
不适用
Observational Study to Assess Protection to Mumps in Children Received One-dose Mumps-containing VaccineParotid Gland InfectionFeverNCT02901990Jiangsu Province Centers for Disease Control and Prevention7,901