This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of BGB-A317 versus placebo with chemoradiotherapy in participants with Localized Esophageal Squamous Cell Carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
370
Administrated at dose of 200 mg intravenously (IV)
Placebo to match tislelizumab
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 occurs first.
Time frame: From date of randomization up to 4 years, approximately
Overall survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Time frame: From date of randomization up to 4 years, approximately
Change from baseline in European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30)
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) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).
Time frame: Baseline to end of treatment ~2 years
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer module (EORTC QLQ-OES18)
Total of 18 questions to assess your symptoms or problems during the past week, each assessed on a scale from 1 (not at all) to 4 (very much). with the range from minimum scores 1 as better outcome and maximum 4 as worst outcomes. Symptoms includes whether any difficulty to eating solids, liquidized or softs food, drinking, or not, whether it is difficult to or swallowing, trouble eating or enjoying meals, pain when eating, dry mouth, food tasting differently, trouble talking, , whether the sense of smell and conversation are normal or not, whether have Symptoms include cough, indigestion or heartburn, acid reflux and pain or not in the chest or stomach.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: Up to 2 years, approximately
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
Time frame: From date of randomization up to 4 years, approximately
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
Time frame: From first determination of an objective response up to 4 years, approximately
Number of Participants with treatment-emergent adverse events (TEAEs)
Adverse events will be graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events
Time frame: Up to 2 years, approximately