NCT05461794终止2 期
Phase 2, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Patients With Locally Advanced Unresectable or Metastatic Esophageal Squamous Cell Carcinoma That Progressed on or After Anti-PD-(L)1 Antibody Therapy
BeiGene31 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2022年10月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 96
- 试验地点
- 31
- 主要终点
- Arms A and C: Overall Response Rate (ORR)
研究概览
简要总结
The study aimed to evaluate the efficacy and safety of sitravatinib in combination with tislelizumab as a second- or third-line treatment for participants with locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) who experienced disease progression following prior systemic chemotherapy.
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
- •Histologically or cytologically confirmed locally advanced unresectable or metastatic ESCC, not amenable to treatment with curative intent
- •At least 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by local site investigator/radiology assessment ≤ 28 days before randomization Note: Lesions that had been previously irradiated were considered evaluable provided
- •Eastern Cooperative Oncology Group (ECOG) score ≤ 1
- •Adequate organ function as indicated by the following laboratory values as indicated by the laboratory tests performed ≤ 7 days before randomization
排除标准
- •Have any contraindication for receiving treatment with both docetaxel and irinotecan
- •Participants with tumor located around important vascular structures as shown by imaging or the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding (ie, radiologic evidence of tumors invading or abutting major blood vessels)
- •Participants with tumor that invades into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) that has an increased risk of fistula during the study treatment period as assessed by the investigator
- •History of gastrointestinal perforation and/or fistula or aorto-esophageal fistula within 6 months before randomization
- •Have received prior anticancer agents that have same mechanism of action as sitravatinib (eg, receptor tyrosine kinases (RTKs) with a similar target profile or Vascular Endothelial Growth Factor (VEGF)/Vascular Endothelial Growth Factor Receptor-targeted (VEGFR) monoclonal antibodies)
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Arm A: Tislelizumab + Sitravatinib
Experimental
Sitravatinib administered orally and tislelizumab administered intravenously
干预措施: Sitravatinib (Drug)
Arm A: Tislelizumab + Sitravatinib
Experimental
Sitravatinib administered orally and tislelizumab administered intravenously
干预措施: Tislelizumab (Drug)
Arm B: Sitravatinib
Experimental
Sitravatinib administered orally
干预措施: Sitravatinib (Drug)
Arm C: Investigator-chosen chemotherapy (ICC)
Experimental
Investigators chose between docetaxel or irinotecan
干预措施: Docetaxel (Drug)
Arm C: Investigator-chosen chemotherapy (ICC)
Experimental
Investigators chose between docetaxel or irinotecan
干预措施: Irinotecan (Drug)
结局指标
主要结局
Arms A and C: Overall Response Rate (ORR)
时间窗: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1.
次要结局
- Duration of Response (DOR)(Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))
- Overall Survival (OS)(Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))
- Clinical Benefit Rate (CBR)(Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))
- Progression Free Survival (PFS)(Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))
- Number of Participants With Adverse Events(From the first dose to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).)
- Disease Control Rate (DCR)(Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))
- Arms A and B: Overall Response Rate (ORR)(Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))
研究者
研究点 (31)
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