AzTrials
AzTrials

Esophageal Squamous Cell CarcinomaPhase 2NCT05461794

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

A Phase 2 study testing Sitravatinib, Tislelizumab and Docetaxel in people with Esophageal Squamous Cell Carcinoma, run by BeiGene at 31 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Sitravatinib, Tislelizumab and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
31 sitesChina
Study dates
3 Oct 2022to 26 Feb 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Beijing Luhe Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610071

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University

    Ganzhou, Jiangxi, 341000

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Sun Yat Sen University Cancer Center(Huangpu Campus)

    Guangzhou, Guangdong, 510700

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Anhui Provincial Hospital South Brance

    Hefei, Anhui, 230036

  • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

    Hefei, Anhui, 230088

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi, 530021

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515031

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Weifang Peoples Hospital

    Weifang, Shandong, 261000

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

  • Northern Jiangsu Peoples Hospital

    Yangzhou, Jiangsu, 225001

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: 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.

Being tested
Sitravatinib, Tislelizumab, Docetaxel, Irinotecan
Keywords
esophageal squamous cell carcinoma
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SitravatinibDrug

    Also called BGB-9468

    100 mg orally once daily

  • TislelizumabDrug

    Also called BGB-A317

    200 mg intravenously once every 3 weeks

  • DocetaxelDrug

    75 milligrams per square meter of body surface area (mg/m2) intravenously on Day 1 of every 21-day cycle

  • IrinotecanDrug

    125 mg/m2 intravenously on Days 1 and 8 of every 21-day cycle

Study groups in NCT05461794
Study groupRoleWhat they receive
Arm A: Tislelizumab + SitravatinibExperimentalSitravatinib administered orally and tislelizumab administered intravenously
Receives: Drug: Sitravatinib; Drug: Tislelizumab
Arm B: SitravatinibExperimentalSitravatinib administered orally
Receives: Drug: Sitravatinib
Arm C: Investigator-chosen chemotherapy (ICC)ExperimentalInvestigators chose between docetaxel or irinotecan
Receives: Drug: Docetaxel; Drug: Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

Secondary outcomes (7)

  1. Duration of Response (DOR)

    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.

    Measured: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

  2. Overall Survival (OS)

    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.

    Measured: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

  3. Disease Control Rate (DCR)

    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

    Measured: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

  4. Clinical Benefit Rate (CBR)

    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.

    Measured: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

  5. Progression Free Survival (PFS)

    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.

    Measured: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

  6. Arms A and B: 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 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)

    Measured: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

  7. Number of Participants With Adverse Events

    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

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2022
  2. Study start3 Oct 2022
  3. Primary completion26 Feb 2024
  4. Study completion26 Feb 2024

Why it stopped: Due to modification of company strategy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05461794
Sponsor's protocol ID
BGB-A317-Sitravatinib-203
Other IDs
CTR20222088
Status last verified
May 2025
First submitted
14 Jul 2022
Last updated
13 Jun 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sitravatinib, Tislelizumab and Docetaxel in people with Esophageal Squamous Cell Carcinoma, run by BeiGene at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05461794.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in