Study Stopped
Due to modification of company strategy.
Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma
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
2 other identifiers
interventional
96
1 country
31
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2022
Shorter than P25 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2022
CompletedFirst Posted
Study publicly available on registry
July 18, 2022
CompletedStudy Start
First participant enrolled
October 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2024
CompletedResults Posted
Study results publicly available
June 13, 2025
CompletedJune 13, 2025
May 1, 2025
1.4 years
July 14, 2022
November 7, 2024
May 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Arms A and C: Overall Response Rate (ORR)
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.
Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
Secondary Outcomes (7)
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)
Disease Control Rate (DCR)
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)
- +2 more secondary outcomes
Study Arms (3)
Arm A: Tislelizumab + Sitravatinib
EXPERIMENTALSitravatinib administered orally and tislelizumab administered intravenously
Arm B: Sitravatinib
EXPERIMENTALSitravatinib administered orally
Arm C: Investigator-chosen chemotherapy (ICC)
EXPERIMENTALInvestigators chose between docetaxel or irinotecan
Interventions
100 mg orally once daily
200 mg intravenously once every 3 weeks
75 milligrams per square meter of body surface area (mg/m2) intravenously on Day 1 of every 21-day cycle
125 mg/m2 intravenously on Days 1 and 8 of every 21-day cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (31)
Anhui Provincial Hospital South Brance
Hefei, Anhui, 230036, China
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, 230088, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Sun Yat Sen University Cancer Center(Huangpu Campus)
Guangzhou, Guangdong, 510700, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441021, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Northern Jiangsu Peoples Hospital
Yangzhou, Jiangsu, 225001, China
Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University
Ganzhou, Jiangxi, 341000, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006, China
Jilin Cancer Hospital
Changchun, Jilin, 130021, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Weifang Peoples Hospital
Weifang, Shandong, 261000, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Data and results should be interpreted with caution due to limited sample size and prematurity of data resulting from early termination and incomplete enrollment.
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2022
First Posted
July 18, 2022
Study Start
October 3, 2022
Primary Completion
February 26, 2024
Study Completion
February 26, 2024
Last Updated
June 13, 2025
Results First Posted
June 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share