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Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Chemoradiotherapy in Participant With ESCC

Primary Purpose

Esophageal Squamous Cell Carcinoma (ESCC)

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Placebo
Paclitaxel
Cisplatin
Radiotherapy
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma (ESCC)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 18 to 75 years on the day of signing the informed consent form
  • Histologically confirmed diagnosis of localized ESCC
  • Measurable and/or non-measurable disease defined per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  • Adequate organ function

Key Exclusion Criteria:

  • Indicators of severe malnutrition
  • Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 2 weeks prior to randomization
  • Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy
  • Received prior radiotherapy or therapies targeting PD-1, PD-L1, PD-L2 or other immune-oncology therapies
  • Active autoimmune diseases or history of autoimmune diseases that may relapse

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tislelizumab + chemoradiotherapy

Placebo combined + chemoradiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

Secondary Outcome Measures

overall response rate (ORR)
duration of response (DOR)
overall survival (OS)
change from baseline in European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30).
Scale consultant including to assess Global health status/Qol with range from minimum scores 1 as worse outcome and maximum scores 7 as higher values represent a better, Physical functioning, role functioning, Emotional functioning, Cognitive functioning, social functioning, fatigue, nausea and vomiting, pain dyspnoea, insomnia, appetite loss, constipation, diarrhea and finical difficulties with range from maximum scores 4 as worse outcome and from minimum scores 1 as higher values represent as better.
change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer module (EORTC QLQ-OES18).
Total 18 questions to assess your symptoms or problems during the past week with the range from minimum scores 1 as better outcome and maximum 4 as worst outcomes. includes whether any difficult to eat solids, liquids food or not， whether it is difficult to swallow ， 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 .
The incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events'.

Full Information

First Posted
May 16, 2019
Last Updated
March 16, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT03957590
Brief Title
Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Chemoradiotherapy in Participant With ESCC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of BGB-A317 versus P placebo with chemoradiotherapy in participants with Localized Esophageal Squamous Cell Carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma (ESCC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
370 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tislelizumab + chemoradiotherapy
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo combined + chemoradiotherapy
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
Administrated at dose of 200 mg intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match tislelizumab
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Administered as 135 mg/m² IV injection
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Administered as 25 mg/m² IV injection
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Administered at a total dose of 50.4 Gy in 28 fractions
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
From date of randomization up to 4 years, approximately
Secondary Outcome Measure Information:
Title
overall response rate (ORR)
Time Frame
From date of randomization up to 4 years, approximately
Title
duration of response (DOR)
Time Frame
From first determination of an objective response up to 4 years, approximately
Title
overall survival (OS)
Time Frame
From date of randomization up to 4 years, approximately
Title
change from baseline in European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30).
Description
Scale consultant including to assess Global health status/Qol with range from minimum scores 1 as worse outcome and maximum scores 7 as higher values represent a better, Physical functioning, role functioning, Emotional functioning, Cognitive functioning, social functioning, fatigue, nausea and vomiting, pain dyspnoea, insomnia, appetite loss, constipation, diarrhea and finical difficulties with range from maximum scores 4 as worse outcome and from minimum scores 1 as higher values represent as better.
Time Frame
From date of randomization to end of treatment ~2 years,
Title
change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer module (EORTC QLQ-OES18).
Description
Total 18 questions to assess your symptoms or problems during the past week with the range from minimum scores 1 as better outcome and maximum 4 as worst outcomes. includes whether any difficult to eat solids, liquids food or not， whether it is difficult to swallow ， 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 .
Time Frame
From date of randomization to end of treatment, ~2years
Title
The incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events'.
Time Frame
From date of enrollment up to 4 years, approximately.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 18 to 75 years on the day of signing the informed consent form Histologically confirmed diagnosis of localized ESCC Measurable and/or non-measurable disease defined per RECIST v1.1 Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 Adequate organ function Key Exclusion Criteria: Indicators of severe malnutrition Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 2 weeks prior to randomization Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy Received prior radiotherapy or therapies targeting PD-1, PD-L1, PD-L2 or other immune-oncology therapies Active autoimmune diseases or history of autoimmune diseases that may relapse NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weihu Wang, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zefen Xiao, MD
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453100
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430023
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Northern Jiangsu people's hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
WeiFang People's Hospital
City
Weifang
State/Province
Shandong
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Sichuan Cancer hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Hangzhou Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310005
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Anyang Cancer Hospital
City
Anyang
ZIP/Postal Code
455001
Country
China
Facility Name
Heping Hospital Affiliated to Changzhi Medical College
City
Changzhi
ZIP/Postal Code
046000
Country
China
Facility Name
Changzhou Cancer Hospital
City
Changzhou
ZIP/Postal Code
213000
Country
China
Facility Name
Chongqing Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
The First Affiliated Hospital of Guangdong Pharmaceutical University
City
Guangzhou
ZIP/Postal Code
510006
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150000
Country
China
Facility Name
Inner Mongolia Autonomous Region Cancer Hospital
City
Hohhot
ZIP/Postal Code
010017
Country
China
Facility Name
Jieyang People's Hospital
City
Jieyang
ZIP/Postal Code
522091
Country
China
Facility Name
Jinhua Municipal Central Hospital
City
Jinhua
ZIP/Postal Code
321000
Country
China
Facility Name
The First People's Hospital of Lianyaungang
City
Lianyungang
ZIP/Postal Code
222002
Country
China
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
ZIP/Postal Code
212001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
34269067
Citation
Yu R, Wang W, Li T, Li J, Zhao K, Wang W, Liang L, Wu H, Ai T, Huang W, Li L, Yu W, Wei C, Wang Y, Shen W, Xiao Z. RATIONALE 311: tislelizumab plus concurrent chemoradiotherapy for localized esophageal squamous cell carcinoma. Future Oncol. 2021 Nov;17(31):4081-4089. doi: 10.2217/fon-2021-0632. Epub 2021 Jul 16.
Results Reference
derived

Learn more about this trial

Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Chemoradiotherapy in Participant With ESCC

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