Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma
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Key facts
- Where
- Beijing, Changchun, Changsha, Chengdu, Fuzhou, Ganzhou, Guangzhou, Hangzhou, Harbin, Hefei, Jinan, Nanchang, Nanning, Shanghai, Shantou, Shenyang, Tianjin, Weifang, Wuhan, Xiangyang, Xinxiang, Yangzhou és Zhengzhou, KínaSee the 31 sites
- Phase
- 2. fázis
Where in Kína
- Beijing Cancer HospitalBeijing, KínaNo longer taking part
- Beijing Friendship Hospital, Capital Medical UniversityBeijing, KínaNo longer taking part
- Beijing Luhe Hospital, Capital Medical UniversityBeijing, KínaNo longer taking part
- Jilin Cancer HospitalChangchun, KínaNo longer taking part
- Hunan Cancer HospitalChangsha, KínaNo longer taking part
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples HospitalChengdu, KínaNo longer taking part
- West China Hospital，Sichuan UniversityChengdu, KínaNo longer taking part
- Fujian Cancer HospitalFuzhou, KínaNo longer taking part
- The First Affiliated Hospital of Fujian Medical UniversityFuzhou, KínaNo longer taking part
- Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang UniversityGanzhou, KínaNo longer taking part
- Sun Yat-sen University Cancer CenterGuangzhou, KínaNo longer taking part
- Sun Yat-Sen University Cancer Center - Huangpu CampusGuangzhou, KínaNo longer taking part
- Zhejiang Cancer HospitalHangzhou, KínaNo longer taking part
- Harbin Medical University Cancer HospitalHarbin, KínaNo longer taking part
- Anhui Provincial Cancer Hospital aka West Branch of Anhui Province HospitalHefei, KínaNo longer taking part
- Anhui Provincial Hospital South BranceHefei, KínaNo longer taking part
- Shandong Cancer HospitalJinan, KínaNo longer taking part
- The First Affiliated Hospital of Nanchang University Branch DonghuNanchang, KínaNo longer taking part
- The Tumor Hospital Affiliated to Guangxi Medical UniversityNanning, KínaNo longer taking part
- Affiliated Zhongshan Hospital of Fudan UniversityShanghai, KínaNo longer taking part
- Rui Jin Hospital Shanghai Jiao Tong University School of MedicineShanghai, KínaNo longer taking part
- Cancer Hospital of Shantou University Medical CollegeShantou, KínaNo longer taking part
- Liaoning Cancer Hospital and InstituteShenyang, KínaNo longer taking part
- Tianjin Medical University General HospitalTianjin, KínaNo longer taking part
- Weifang Peoples HospitalWeifang, KínaNo longer taking part
- Union Hospital of Tongji Medical College Huazhong University of Science and TechnologyWuhan, KínaNo longer taking part
- Xiangyang Central HospitalXiangyang, KínaNo longer taking part
- The First Affiliated Hospital of Xinxiang Medical UniversityXinxiang, KínaNo longer taking part
- Northern Jiangsu Peoples hospitalYangzhou, KínaNo longer taking part
- Henan Cancer HospitalZhengzhou, KínaNo longer taking part
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, KínaNo longer taking part
Trial details
- Who runs it
- BeiGene
- Trial code
- NCT05461794
- Record updated
- 2025. június 13.
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Have any contraindication for receiving treatment with both docetaxel and irinotecan; 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; 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.