NCT06649292招募中3 期
An Open, Randomized,Positive Control, Multicenter Phase III Clinical Study of SHR A1904 for Injection Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patients With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 524
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients
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
- •Age 18 to 75 years old (including boundary values)
- •Volunteer to participate in this clinical study and sign informed consent;
- •ECOG score 0-1;
- •Expected survival ≥3 months;
- •Gastric or Gastroesophageal Junction Adenocarcinoma;
- •positive CLDN18.2 expression in tumor tissue;
- •There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria;
- •Adequate bone marrow and organ function.
排除标准
- •Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study
- •HER2 posotive (IHC 3+ or IHC 2+/ISH +);
- •Toxicities caused by previous anticancer therapy were not recovered to CTCAE 5.0 Grade≤1;
- •Individuals with Leptomeningeal metastasis or Active brain metastases;
- •Individuals with a history of GI perforation or fistula, unstable GI bleeding;
- •Individuals with a history of severe cardiovascular and cerebrovascular diseases;
- •The researcher determined that there are other situations that are not suitable for participation.
研究组 & 干预措施
Treatment group A: SHR-A1904
Experimental
干预措施: SHR-A1904 (Drug)
Treatment group B: Paclitaxel, Docetaxel, Irinotecan.
Active Comparator
干预措施: Paclitaxel, Docetaxel, Irinotecan (Drug)
结局指标
主要结局
Overall Survival
时间窗: Until death, assessed up to approximately 2 years
Measure description: Defined as time from randomization until the date of death due to any cause
次要结局
- Progression-free survival (PFS) by investigator assessment(Until progression or death, assessed up to approximately 1 year)
- Objective response rate (ORR) by investigator assessment(Until progression, assessed up to approximately 1 year)
- Duration of response (DOR) by investigator assessment(Until progression or death, assessed up to approximately 1 year)
- Disease control rate (DCR) by investigator assessment(Until progression, assessed up to approximately 1 year)
- Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)(until to 90 days after the last dose，assessed up to approximately 2 years)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
3 期
SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical TrialBreast CancerNCT05814354Jiangsu HengRui Medicine Co., Ltd.551
招募中
3 期
SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing RegimenHER2-positive Advanced Gastric Cancer or Gastroesophageal Junction AdenocarcinomaNCT06123494Jiangsu HengRui Medicine Co., Ltd.360
招募中
2 期
A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic AscitesCirrhotic AscitesNCT04835480Healthgen Biotechnology Corp.220
招募中
1 期
Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid TumorsAdvanced Solid TumorNCT05765032Suzhou Suncadia Biopharmaceuticals Co., Ltd.120
已完成
3 期
Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess BlastsMyelodysplastic SyndromesMDSRAEBChronic Myelomonocytic LeukemiaNCT01241500Traws Pharma, Inc.299