Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma
- Conditions
- Esophageal Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT05461794
- Lead Sponsor
- BeiGene
- Brief Summary
The purpose of this study is to investigate the efficacy and safety of sitravatinib in combination with tislelizumab for the treatment of participants with esophageal squamous cell carcinoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 96
- 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 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
- ECOG PS score ≤ 1
- Adequate organ function as indicated by the following laboratory values as indicated by the laboratory tests performed ≤ 7 days before randomization
Key
- Have any contraindication for receiving treatment with both docetaxel and irinotecan
- Patients 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)
- Patients 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, RTK inhibitor with a similar target profile or VEGF- or VEGFR-targeted monoclonal antibodies) ther protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Sitravatinib Sitravatinib Sitravatinib administered orally Arm A: Sitravatinib + Tislelizumab Sitravatinib Sitravatinib administered orally and tislelizumab administered intravenously Arm A: Sitravatinib + Tislelizumab Tislelizumab Sitravatinib administered orally and tislelizumab administered intravenously Arm C: Investigator-chosen Chemotherapy Docetaxel Docetaxel or Irinotecan Arm C: Investigator-chosen Chemotherapy Irinotecan Docetaxel or Irinotecan
- Primary Outcome Measures
Name Time Method Arms A and C: Overall Response Rate (ORR) Up to 2 Years ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) Up to 2 Years defined as the time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first
Arms A and C: Overall Survival (OS) Up to 2 Years OS is defined as the time from the date of randomization to the date of death due to any cause
Number of participants with adverse events (AEs) Up to 2 Years Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Clinical Benefit Rate (CBR) Up to 2 Years CBR is defined as the percentage of participants who have complete response, partial response, and stable disease, as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Number of participants with clinically significant changes from baseline in vital signs Up to 2 Years Vital signs include blood pressure and pulse rate
Disease Control Rate (DCR) Up to 2 Years DCR is defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Number of participants with clinically significant changes from baseline in clinical laboratory values Up to 2 Years Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
Progression Free Survival (PFS) Up to 2 Years PFS is defined as the time from the date of randomization until first documentation of progression or death, whichever comes first, as assessed by the investigator Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Overall Response Rate (ORR) as assessed by the investigator Up to 2 Years defined as the proportion of patients with a confirmed complete response or partial response per RECIST v1.1
Trial Locations
- Locations (27)
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
🇨🇳Chengdu, Sichuan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, China
Anhui Provincial Hospital South Brance
🇨🇳Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
🇨🇳Hefei, Anhui, China
Northern Jiangsu Peoples Hospital
🇨🇳Yangzhou, Jiangsu, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
The Tumor Hospital Affiliated to Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Beijing Luhe Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Cancer Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Sun Yat Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Xiangyang Central Hospital
🇨🇳Xiangyang, Hubei, China
Sun Yat Sen University Cancer Center(Huangpu Campus)
🇨🇳Guangzhou, Guangdong, China
Affiliated Zhongshan Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University
🇨🇳Ganzhou, Jiangxi, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Liaoning Cancer Hospital and Institute
🇨🇳Shenyang, Liaoning, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China