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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
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
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.
Time frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
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.
Time frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
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.
Time frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
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
Time frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
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.
Time frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
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125 mg/m2 intravenously on Days 1 and 8 of every 21-day cycle
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 Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yat Sen University Cancer Center(Huangpu Campus)
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
...and 21 more locations
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.
Time frame: 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)
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)
Time frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
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
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).