NCT07790380尚未招募3 期
A Randomized, Open-label, Multicenter, Phase III Study of FH-006 Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma Who Have Failed Prior PD-1/PD-L1 Inhibitor Combined With Platinum-Based Chemotherapy.
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
- 480
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The study compares the overall survival (OS) of FH-006 and the second-line chemotherapy selected by the investigators for treating esophageal squamous cell carcinoma 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;
- •Patients diagnosed with esophageal squamous cell carcinoma by histological or cytological examination;
- •Previously, only PD-1/PD-L1 Inhibitor Combined With Platinum-Based Chemotherapy were received;
- •There is at least one measurable 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
- •Toxicities caused by previous anticancer therapy were not recovered to CTCAE 6.0 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.
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 30 days after the last dose，assessed up to approximately 2 years)
研究者
研究点 (1)
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