Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma

May 29, 2025 updated by: BeiGene

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230088
        • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
      • Hefei, Anhui, China, 230036
        • Anhui Provincial Hospital South Brance
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing, China, 100050
        • Beijing Friendship hospital, Capital Medical University
      • Beijing, Beijing, China, 101149
        • Beijing Luhe Hospital, Capital Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Cancer Hospital
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat Sen University Cancer Center
      • Guangzhou, Guangdong, China, 510700
        • Sun Yat Sen University Cancer Center(Huangpu Campus)
      • Shantou, Guangdong, China, 515031
        • Cancer Hospital of Shantou University Medical College
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The Tumor Hospital Affiliated to Guangxi Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin Medical University Cancer Hospital
    • Henan
      • Xinxiang, Henan, China, 453100
        • The First Affiliated Hospital of Xinxiang Medical University
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
      • Xiangyang, Hubei, China, 441021
        • Xiangyang Central Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Northern Jiangsu Peoples Hospital
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University Branch Donghu
    • Jilin
      • Changchun, Jilin, China, 130021
        • Jilin cancer hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Liaoning Cancer Hospital and Institute
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital
      • Weifang, Shandong, China, 261000
        • Weifang Peoples Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
      • Shanghai, Shanghai, China, 200032
        • Affiliated Zhongshan Hospital of Fudan University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, China, 610071
        • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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
  3. Eastern Cooperative Oncology Group (ECOG) 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. 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)
  3. 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
  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, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm B: Sitravatinib
Sitravatinib administered orally
Drug: Sitravatinib
100 mg orally once daily
Other Names:
  • BGB-9468
Experimental: Arm A: Tislelizumab + Sitravatinib
Sitravatinib administered orally and tislelizumab administered intravenously
Drug: Sitravatinib
100 mg orally once daily
Other Names:
  • BGB-9468
Drug: Tislelizumab
200 mg intravenously once every 3 weeks
Other Names:
  • BGB-A317
Experimental: Arm C: Investigator-chosen chemotherapy (ICC)
Investigators chose between docetaxel or irinotecan
Drug: Docetaxel
75 milligrams per square meter of body surface area (mg/m2) intravenously on Day 1 of every 21-day cycle
Drug: Irinotecan
125 mg/m2 intravenously on Days 1 and 8 of every 21-day cycle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Arms A and C: Overall Response Rate (ORR)
Time Frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)
Time Frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
Defined as the time from the first occurrence of a documented objective response to the time of documented disease progression assessed by the investigator or death from any cause, whichever occurred first, in all randomized participants with documented objective responses.
Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
Overall Survival (OS)
Time Frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
Defined as the time from randomization until the date of death due to any cause. Kaplan-Meier methodology was used to estimate the median OS.
Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
Disease Control Rate (DCR)
Time Frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
Defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as assessed by the investigator per RECIST v1.1
Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
Clinical Benefit Rate (CBR)
Time Frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
Defined as the percentage of participants with a complete response, partial response, or durable stable disease (defined as stable disease for 24 weeks or longer, as assessed by the investigator per RECIST v.1.1.
Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
Progression Free Survival (PFS)
Time Frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
Defined as the time from randomization until first documentation of disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Kaplan-Meier methodology was used to estimate the median PFS.
Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
Arms A and B: Overall Response Rate (ORR)
Time Frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1. Analysis of ORR in Arm A compared to Arm B was specified as a secondary endpoint in the Protocol (please see the primary outcome measure for Arm C results)
Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
Number of Participants With Adverse Events
Time Frame: From the first dose to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, and vital signs, according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
From the first dose to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BeiGene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BGB-A317-Sitravatinib-203
  • CTR20222088 (Other Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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