This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of tislelizumab (BGB-A317) versus placebo in combination with chemoradiotherapy in participants with localized esophageal squamous cell carcinoma (ESCC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
370
Administered intravenously (IV)
Placebo to match tislelizumab administered intravenously
Administered as 135 mg/m² IV injection
Progression-free Survival (PFS)
PFS is defined as the time from randomization to the first documented disease progression, as determined by the Blinded Independent Review Committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occurred first. PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, and/or unequivocal progression of existing nontarget lesions. or the appearance of one or more new lesions.
Time frame: From randomization to the prespecified primary analysis data cut-off date of 08 January 2025; maximum time on study was 67 months.
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause. OS was estimated using the Kaplan-Meier method.
Time frame: From randomization to the prespecified analysis data cut-off date of 08 January 2025; maximum time on study was 67 months.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Oesophageal Cancer Module (OES18) Dysphagia, Reflux, Pain, and Eating Scales
The EORTC-QLQ-OES18 is the specific esophageal symptoms module of the QLQ-C30. QLQ-OES18 is comprised of 18 questions grouped into 4 multi-item subscales: Dysphagia (3 items), Eating (4 items), Reflux (2 items), and Pain (3 items) and 6 single item subscales (saliva swallowing, choking, dry mouth, taste, coughing, and talking). Participants indicate the extent to which they have experienced symptoms on a scale from 1 (Not at all) to 4 (Very much). Scores are calculated and transformed to a scale from 0 to 100; higher scores indicate a higher level of symptomatology or problems.
Time frame: Baseline and Cycle 6 and Cycle 10 (each cycle was 21 days)
Change From Baseline in EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning, and Fatigue Scores
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Administered as 25 mg/m² IV injection
Administered at a total dose of 50.4 Gy in 28 fractions
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First Affiliated Hospitalschool of Clinical Medicine of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University )
Jieyang, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
...and 23 more locations
The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. Lower scores in symptom scales indicate better quality of life.
Time frame: Baseline and Cycle 6 and Cycle 10 (each cycle was 21 days)
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by BIRC per RECIST v1.1. Tumor assessments were made using computed tomography (CT) scans or using magnetic resonance imaging (MRI). CR: Disappearance of all target lesions and non-target lesions, no new lesions, and normalization of tumor marker level. All lymph nodes must be nonpathological in size (\<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and/or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.
Time frame: Tumor assessments occurred every 9 weeks for the first 54 weeks, and every 12 weeks during the next 2 years and every 24 weeks thereafter until radiographic disease progression or death; up to 67 months
Duration of Response (DOR)
DOR is defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by the BIRC per RECIST v1.1, or death from any cause, whichever occurs first. DOR was estimated using the Kaplan-Meier method.
Time frame: Up to 67 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment, whether considered related to study treatment or not. A TEAE is an AE that had an onset date or a worsening in severity from baseline on or after the first dose of study treatment and up to 30 days following study treatment discontinuation or initiation of new anticancer therapy, whichever occurred first. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the investigator based on medical judgement.
Time frame: From first dose of study drug to 30 days after last dose, maximum time on treatment was 57.5 months