A Randomized, Open-Label, Multicenter, Phase I/III Clinical Study to Evaluate the Pharmacokinetics, Efficacy and Safety of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Regimen Versus AK104 (IV) in Combination With XELOX Regimen as First-Line Treatment for Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 422
- 主要终点
- Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2).
研究概览
简要总结
A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
- •Unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
- •Participants have not received prior systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
- •Adequate organ and bone marrow function.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
- •Measurable disease by RECIST 1.1.
排除标准
- •Receipt of systemic non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymic peptides, etc.) within 2 weeks prior to the first dose.Receipt of Chinese herbal medicines or Chinese patent medicines with anti-tumor indications within 2 weeks prior to the first dose.
- •Deep venous thrombosis within 3 months before first treatment.
- •Uncontrolled arterial hypertension.
- •Bleeding events within the last 1 months.
- •Prior treatment with immune checkpoint inhibitors.
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
研究组 & 干预措施
AK104(SC)+XELOX
AK104 SC plus XELOX
干预措施: AK104(SC) (Drug)
AK104(SC)+XELOX
AK104 SC plus XELOX
干预措施: Capecitabine (Drug)
AK104(SC)+XELOX
AK104 SC plus XELOX
干预措施: Oxaliplatin injection (Drug)
AK104(IV)+XELOX
AK104 IV plus XELOX
干预措施: AK104(IV) (Drug)
AK104(IV)+XELOX
AK104 IV plus XELOX
干预措施: Capecitabine (Drug)
AK104(IV)+XELOX
AK104 IV plus XELOX
干预措施: Oxaliplatin injection (Drug)
结局指标
主要结局
Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2).
时间窗: up to 4 weeks
Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2).
Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration.
时间窗: up to 4 weeks
Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration.
次要结局
- Disease Control Rate (DCR) per RECIST 1.1(Up to 24 months)
- Objective Response Rate (ORR) per RECIST 1.1(up to 24 months)
- Progression-free survival (PFS) assessed by investigator per RECIST v1.1(Up to 24 months)
- Duration of Response (DOR) assessed by investigator per RECIST v1.1(Up to 24 months)
- Time to Response (TTR) assessed by investigator per RECIST v1.1(Up to 24 months)
- Overall Survival(Up to 24 months)
- Number of participants with adverse event (AE)(Up to 27 months)