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.

A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma (ESCC)

Tislelizumab

Placebo

Paclitaxel

Cisplatin

Radiotherapy

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Localized Esophageal Squamous Cell Carcinoma

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.

OS is defined as the time from the date of randomization to the date of death due to any
cause.

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).

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.

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

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

Adverse events will be graded according to National Cancer Institute-Common Terminology
Criteria for Adverse Events

Tislelizumab once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a
total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2
cycles + Radiotherapy

Placebo once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total
of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles +
Radiotherapy

Cancer Hospital Chinese Academy of Medical Sciences

Beijing Cancer Hospital

Fujian Cancer Hospital

First Affiliated Hospital of Xiamen University

The First Affiliated Hospital of Xinxiang Medical University

Henan Cancer Hospital

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Hubei Cancer Hospital

Hunan Cancer Hospital

Jiangsu Province Hospital

The Affiliated Hospital of Xuzhou Medical University

Northern Jiangsu people's hospital

Liaoning Cancer Hospital

Shandong Cancer Hospital

WeiFang People's Hospital

Fudan University Shanghai Cancer Center

Sichuan Cancer hospital

West China Hospital of Sichuan University

Tianjin Medical University Cancer Institute & Hospital

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou Cancer Hospital

The First Affiliated Hospital of College of Medicine, Zhejiang University

Anyang Cancer Hospital

Heping Hospital Affiliated to Changzhi Medical College

Changzhou Cancer Hospital

Chongqing Cancer Hospital

The First Affiliated Hospital of Guangdong Pharmaceutical University

Harbin Medical University Cancer Hospital

Inner Mongolia Autonomous Region Cancer Hospital

Jieyang People's Hospital

Jinhua Municipal Central Hospital

The First People's Hospital of Lianyaungang

First Affiliated Hospital of Xi'an Jiaotong University

Affiliated Hospital of Jiangsu University

A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the Participation Requirements?