NCT07716449尚未招募3 期
A Randomized, Open-label, Multicenter Phase III Clinical Study of QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic CLDN18.2-positive, PD-L1 CPS < 5 Gastric or Gastroesophageal Junction Adenocarcinoma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 560
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This study is a randomized, open, multicenter phase III clinical study designed to compare the efficacy and safety of QLS31905 injection combined with CAPOX versus sintilimab combined with CAPOX in the first-line treatment of CLDN18.2 positive, PD-L1 CPS < 5 unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participate in the study and sign the informed consent form;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- •Expected survival time ≥ 12 weeks;
- •Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma;
- •No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease;
- •At least one measurable lesion per RECIST v1.1;
- •Patients with adequate cardiac, liver, renal function, etc.
排除标准
- •Known history of allergy to any component of the study drug;
- •Other second primary malignant neoplasm within 5 years;
- •Significant cardiovascular and cerebrovascular disorders within 6 months before randomization;
- •Haemorrhage requiring haemostatic treatment within 3 months prior to randomisation;
- •Previous or current interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, etc;
- •Previous treatment targeting CLDN18.2;
- •Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator.
结局指标
主要结局
Progression free survival (PFS)
时间窗: Up to 44 months
PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease by Blinded Independent Central Review (BICR) evaluation or death due to any cause (whichever occurs first).
次要结局
未报告次要终点
研究者
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