NCT07487896招募中3 期
A Randomized, Controlled, Multicenter Phase III Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-Line Therapy (TAISHAN-303)
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
- 440
- 试验地点
- 81
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a large clinical study carried out at multiple hospitals. Participants will be randomly assigned to one of two groups: one group will receive a new medicine called YL201, and the other group will receive standard chemotherapy chosen by the doctor.
The purpose of the study is to see whether YL201 works better and is safer for people with locally advanced or metastatic esophageal squamous cell carcinoma whose first-line treatment has stopped working.
The study will also look at how YL201 is processed in the body (Pharmacokinetics), whether it triggers any immune reactions, and whether certain biological markers can help predict how well it works.
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
- •Age: ≥18 years;
- •Voluntary participation in this study with signed informed consent and good compliance.
- •ECOG PS score: 0-1;
- •estimated life expectancy >3 months;
- •Histologically or cytologically confirmed ESCC with unresectable locally advanced or metastatic disease
- •Previously received one line of systemic standard therapy for unresectable locally advanced or metastatic ESCC and experienced disease progression
- •Adequate organ function.
- •At least one measurable lesion
- •Willing to provide biopsy or archived tumor tissue.
排除标准
- •Other malignancies within 5 years prior to first dose or currently concurrent malignancies.
- •Prior treatment-related adverse events not resolved to ≤Grade 1 per CTCAE v5.0, except for alopecia (any grade), hyperpigmentation (any grade), peripheral neuropathy (≤ Grade 2), and lymphopenia (≤ Grade 3).
- •Major surgery, significant traumatic injury within 4 weeks prior to first dose, or anticipated need for major surgery during study treatment
- •Any arterial thromboembolic event within 6 months prior to randomization, or venous thromboembolic events of Grade ≥ 3 according to NCI CTCAE version 5.
- •Known active tuberculosis (TB). Participants suspected of having active TB must undergo clinical evaluation to rule it out.
- •History of immunodeficiency or positive test for human immunodeficiency virus (HIV) antibodies. Participants with known active syphilis infection are also excluded.
- •Current active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
- •Known allergy to any component of the investigational product; history of severe allergic reactions (e.g., anaphylactic shock); or known history of severe hypersensitivity reactions to other monoclonal antibodies or recombinant proteins, or previous severe infusion reactions.
- •Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study period.
- •Any disease, medical condition, organ dysfunction, or social/psychological circumstance that, in the investigator's judgment, may interfere with the participant's ability to sign the informed consent form (ICF), compromise cooperation or compliance with study procedures, or affect the interpretation of study results. This includes, but is not limited to, psychiatric disorders, substance/alcohol abuse, or a history of drug abuse.
研究组 & 干预措施
Control
Active Comparator
Investigator's choice of Chemotherapy
干预措施: Paclitaxel (Drug)
Control
Active Comparator
Investigator's choice of Chemotherapy
干预措施: Docetaxel (Drug)
YL201
Experimental
YL201 monotherapy
干预措施: YL201 (Drug)
Control
Active Comparator
Investigator's choice of Chemotherapy
干预措施: Irinotecan (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to Approximately 36 Months
OS is defined as the time from randomization to the event of death from any cause.
次要结局
- Progression-Free Survival (PFS)(Up to Approximately 36 Months)
- Overall response rate (ORR)(Up to Approximately 36 Months)
- Disease control rate (DCR)(Up to Approximately 36 Months)
- Duration of Response (DOR)(Up to Approximately 36 Months)
- Adverse Event (AE)(Up to Approximately 36 Months)
研究者
研究点 (81)
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