The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
512
200 mg administered intravenously (IV)
135-175 mg /m² administered IV , or 80-100 mg/m\^2 administered IV according to local guidelines for standard of care
75 mg/m\^2 administered IV or 70 mg/m\^2 IV in Japan
Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set
OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants
Time frame: Approximately 2 years and 10 months from date of first randomization
Overall Survival (OS) in the PDL-1 Positive Analysis Set
OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%.
Time frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Objective Response Rate (ORR) in the ITT Analysis Set
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
Time frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1;
Time frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Progression-free Survival (PFS) in the ITT Analysis Set
PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the ITT analysis set
Time frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
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125 mg/m\^2 administered IV
Henry Ford Hospital
Detroit, Michigan, United States
Toledo Clinic Cancer Center
Toledo, Ohio, United States
Imelda Ziekenhuis Bonheiden
Bonheiden, Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
Uz Antwerpen
Edegem, Belgium
University Hospitals Leuven
Leuven, Belgium
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
...and 94 more locations
Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set
PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the PDL-1 Positive Analysis Set
Time frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Duration of Response (DOR) in the ITT Analysis Set
DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
Time frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Duration of Response (DOR) in the PDL-1 Positive Analysis Set.
DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
Time frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set
Mean change from baseline in EORTC QLQ-C30 index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes
Time frame: Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set
Mean change from baseline in EORTC QLQ-C30 Index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes
Time frame: Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set
Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
Time frame: Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set.
Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
Time frame: Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set
Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.
Time frame: Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set
Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.
Time frame: Baseline to Cycle 6 (21 days per cycle)
Number of Participants Experiencing Adverse Events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs
Time frame: From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months