Back to resultsStudy To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sitravatinib
Tislelizumab
Docetaxel
Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring esophageal squamous cell carcinoma
Eligibility Criteria
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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.
Sites / Locations
- Anhui Provincial Hospital South Brance
- Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
- Beijing Friendship Hospital, Capital Medical University
- Beijing Cancer Hospital
- Beijing Luhe Hospital, Capital Medical University
- The First Affiliated Hospital of Fujian Medical University
- Fujian Cancer Hospital
- Sun Yat Sen University Cancer Center
- Sun Yat Sen University Cancer Center(Huangpu Campus)
- Cancer Hospital of Shantou University Medical College
- The Tumor Hospital Affiliated to Guangxi Medical University
- Harbin Medical University Cancer Hospital
- The First Affiliated Hospital of Xinxiang Medical University
- Henan Cancer Hospital
- The First Affiliated Hospital of Zhengzhou University
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
- Xiangyang Central Hospital
- Northern Jiangsu Peoples Hospital
- Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University
- The First Affiliated Hospital of Nanchang University Branch Donghu
- Jilin Cancer Hospital
- Liaoning Cancer Hospital and Institute
- Shandong Cancer Hospital
- Weifang Peoples Hospital
- Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
- Affiliated Zhongshan Hospital of Fudan University
- West China Hospital, Sichuan University
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
- Tianjin Medical University General Hospital
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm A: Sitravatinib + Tislelizumab
Arm B: Sitravatinib
Arm C: Investigator-chosen Chemotherapy
Arm Description
Sitravatinib administered orally and tislelizumab administered intravenously
Sitravatinib administered orally
Docetaxel or Irinotecan
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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
Number of participants with adverse events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Number of participants with clinically significant changes from baseline in clinical laboratory values
Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
Number of participants with clinically significant changes from baseline in vital signs
Vital signs include blood pressure and pulse rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05461794
Brief Title
Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma
Official Title
A 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
esophageal squamous cell carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Sitravatinib + Tislelizumab
Arm Type
Experimental
Arm Description
Sitravatinib administered orally and tislelizumab administered intravenously
Arm Title
Arm B: Sitravatinib
Arm Type
Experimental
Arm Description
Sitravatinib administered orally
Arm Title
Arm C: Investigator-chosen Chemotherapy
Arm Type
Experimental
Arm Description
Docetaxel or Irinotecan
Intervention Type
Drug
Intervention Name(s)
Sitravatinib
Intervention Description
administered orally
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
administered intravenously
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
administered intravenously
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
administered intravenously
Primary Outcome Measure Information:
Title
Arms A and C: Overall Response Rate (ORR)
Description
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
Time Frame
Up to 2 Years
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
defined as the time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first
Time Frame
Up to 2 Years
Title
Arms A and C: Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of death due to any cause
Time Frame
Up to 2 Years
Title
Disease Control Rate (DCR)
Description
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
Time Frame
Up to 2 Years
Title
Clinical Benefit Rate (CBR)
Description
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
Time Frame
Up to 2 Years
Title
Progression Free Survival (PFS)
Description
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
Time Frame
Up to 2 Years
Title
Overall Response Rate (ORR) as assessed by the investigator
Description
defined as the proportion of patients with a confirmed complete response or partial response per RECIST v1.1
Time Frame
Up to 2 Years
Title
Number of participants with adverse events (AEs)
Description
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame
Up to 2 Years
Title
Number of participants with clinically significant changes from baseline in clinical laboratory values
Description
Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
Time Frame
Up to 2 Years
Title
Number of participants with clinically significant changes from baseline in vital signs
Description
Vital signs include blood pressure and pulse rate
Time Frame
Up to 2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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 Exclusion Criteria:
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.
Facility Information:
Facility Name
Anhui Provincial Hospital South Brance
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230036
Country
China
Facility Name
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230088
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Beijing Luhe Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Sun Yat Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Sun Yat Sen University Cancer Center(Huangpu Campus)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510700
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515031
Country
China
Facility Name
The Tumor Hospital Affiliated to Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453100
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Xiangyang Central Hospital
City
Xiangyang
State/Province
Hubei
ZIP/Postal Code
441021
Country
China
Facility Name
Northern Jiangsu Peoples Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
341000
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University Branch Donghu
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Liaoning Cancer Hospital and Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Weifang Peoples Hospital
City
Weifang
State/Province
Shandong
ZIP/Postal Code
261000
Country
China
Facility Name
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Affiliated Zhongshan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610071
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma
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