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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05461794
Other study ID # BGB-A317-Sitravatinib-203
Secondary ID CTR20222088
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 3, 2022
Est. completion date February 26, 2024

Study information

Verified date November 2023
Source BeiGene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Terminated
Enrollment 96
Est. completion date February 26, 2024
Est. primary completion date February 26, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: 1. Histologically or cytologically confirmed locally advanced unresectable or metastatic ESCC, not amenable to treatment with curative intent 2. 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 3. ECOG PS score = 1 4. Adequate organ function as indicated by the following laboratory values as indicated by the laboratory tests performed = 7 days before randomization Key Exclusion Criteria: 1. Have any contraindication for receiving treatment with both docetaxel and irinotecan 2. 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) 3. 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 4. . History of gastrointestinal perforation and/or fistula or aorto-esophageal fistula within 6 months before randomization 5. 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


Related Conditions & MeSH terms


Intervention

Drug:
Sitravatinib
administered orally
Tislelizumab
administered intravenously
Docetaxel
administered intravenously
Irinotecan
administered intravenously

Locations

Country Name City State
China Beijing Cancer Hospital Beijing Beijing
China Beijing Friendship Hospital, Capital Medical University Beijing Beijing
China Beijing Luhe Hospital, Capital Medical University Beijing Beijing
China Jilin Cancer Hospital Changchun Jilin
China Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Chengdu Sichuan
China West China Hospital, Sichuan University Chengdu Sichuan
China Fujian Cancer Hospital Fuzhou Fujian
China The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
China Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University Ganzhou Jiangxi
China Sun Yat Sen University Cancer Center Guangzhou Guangdong
China Sun Yat Sen University Cancer Center(Huangpu Campus) Guangzhou Guangdong
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China Harbin Medical University Cancer Hospital Harbin Heilongjiang
China Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital Hefei Anhui
China Anhui Provincial Hospital South Brance Hefei Anhui
China Shandong Cancer Hospital Jinan Shandong
China The Tumor Hospital Affiliated to Guangxi Medical University Nanning Guangxi
China Affiliated Zhongshan Hospital of Fudan University Shanghai Shanghai
China Rui Jin Hospital Shanghai Jiao Tong University School of Medicine Shanghai Shanghai
China Cancer Hospital of Shantou University Medical College Shantou Guangdong
China Liaoning Cancer Hospital and Institute Shenyang Liaoning
China Tianjin Medical University General Hospital Tianjin Tianjin
China Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
China Xiangyang Central Hospital Xiangyang Hubei
China The First Affiliated Hospital of Xinxiang Medical University Xinxiang Henan
China Northern Jiangsu Peoples Hospital Yangzhou Jiangsu
China Henan Cancer Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arms A and C: Overall Response Rate (ORR) 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 Up to 2 Years
Secondary Duration of Response (DOR) defined as the time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first Up to 2 Years
Secondary Arms A and C: Overall Survival (OS) OS is defined as the time from the date of randomization to the date of death due to any cause Up to 2 Years
Secondary Disease Control Rate (DCR) 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 Up to 2 Years
Secondary Clinical Benefit Rate (CBR) 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 Up to 2 Years
Secondary Progression Free Survival (PFS) 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 Up to 2 Years
Secondary Overall Response Rate (ORR) as assessed by the investigator defined as the proportion of patients with a confirmed complete response or partial response per RECIST v1.1 Up to 2 Years
Secondary Number of participants with adverse events (AEs) Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) Up to 2 Years
Secondary Number of participants with clinically significant changes from baseline in clinical laboratory values Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis Up to 2 Years
Secondary Number of participants with clinically significant changes from baseline in vital signs Vital signs include blood pressure and pulse rate Up to 2 Years
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