Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma
- Conditions
- Esophageal Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT05461794
- Lead Sponsor
- BeiGene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 96
- 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
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Tislelizumab + Sitravatinib Sitravatinib Sitravatinib administered orally and tislelizumab administered intravenously Arm A: Tislelizumab + Sitravatinib Tislelizumab Sitravatinib administered orally and tislelizumab administered intravenously Arm B: Sitravatinib Sitravatinib Sitravatinib administered orally Arm C: Investigator-chosen chemotherapy (ICC) Irinotecan Investigators chose between docetaxel or irinotecan Arm C: Investigator-chosen chemotherapy (ICC) Docetaxel Investigators chose between docetaxel or irinotecan
- Primary Outcome Measures
Name Time Method Arms A and C: Overall Response Rate (ORR) 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.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) 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.
Overall Survival (OS) 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.
Clinical Benefit Rate (CBR) 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.
Progression Free Survival (PFS) 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.
Number of Participants With Adverse Events 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
Disease Control Rate (DCR) 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
Arms A and B: Overall Response Rate (ORR) 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)
Trial Locations
- Locations (31)
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University Branch Donghu
🇨🇳Nanchang, Jiangxi, China
Weifang Peoples Hospital
🇨🇳Weifang, Shandong, China
Anhui Provincial Hospital South Brance
🇨🇳Hefei, Anhui, China
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
🇨🇳Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Beijing Luhe Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Scroll for more (21 remaining)The First Affiliated Hospital of Zhengzhou University🇨🇳Zhengzhou, Henan, China