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出境医 / 临床实验 / Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Chemoradiotherapy in Participant With ESCC

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

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 Placebo with chemoradiotherapy in participants with Localized Esophageal Squamous Cell Carcinoma.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma (ESCC) Drug: Tislelizumab Drug: Placebo Drug: Paclitaxel Drug: Cisplatin Radiation: Radiotherapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 12, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : October 30, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Tislelizumab + chemoradiotherapy
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
 Drug: Tislelizumab
Administrated at dose of 200 mg intravenously (IV)
Other Name: BGB-A317

Drug: Paclitaxel
Administered as 135 mg/m² IV injection

Drug: Cisplatin
Administered as 25 mg/m² IV injection

Radiation: Radiotherapy
Administered at a total dose of 50.4 Gy in 28 fractions
Placebo Comparator: Placebo combined + chemoradiotherapy
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
 Drug: Placebo
Placebo to match tislelizumab

Drug: Paclitaxel
Administered as 135 mg/m² IV injection

Drug: Cisplatin
Administered as 25 mg/m² IV injection

Radiation: Radiotherapy
Administered at a total dose of 50.4 Gy in 28 fractions
Outcome Measures
Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: From date of randomization up to 4 years, approximately ]

Secondary Outcome Measures :
  1. overall response rate (ORR) [ Time Frame: From date of randomization up to 4 years, approximately ]
  2. duration of response (DOR) [ Time Frame: From first determination of an objective response up to 4 years, approximately ]
  3. overall survival (OS) [ Time Frame: From date of randomization up to 4 years, approximately ]
  4. change from baseline in European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30). [ Time Frame: From date of randomization to end of treatment ~2 years, ]
    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.

  5. change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer module (EORTC QLQ-OES18). [ Time Frame: From date of randomization to end of treatment, ~2years ]
    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 .

  6. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations

Contacts
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Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com

Locations
Show Show 32 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Weihu Wang, MD Beijing Cancer Hospital
Principal Investigator: Zefen Xiao, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE June 12, 2019
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019) 		Progression-free survival (PFS) [ Time Frame: From date of randomization up to 4 years, approximately ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2020)
  • overall response rate (ORR) [ Time Frame: From date of randomization up to 4 years, approximately ]
  • duration of response (DOR) [ Time Frame: From first determination of an objective response up to 4 years, approximately ]
  • overall survival (OS) [ 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). [ Time Frame: From date of randomization to end of treatment ~2 years, ]
    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). [ Time Frame: From date of randomization to end of treatment, ~2years ]
    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'. [ Time Frame: From date of enrollment up to 4 years, approximately. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • overall response rate (ORR) [ Time Frame: From date of randomization up to 4 years, approximately ]
  • duration of response (DOR) [ Time Frame: From first determination of an objective response up to 4 years, approximately ]
  • overall survival (OS) [ Time Frame: From date of randomization up to 4 years, approximately ]
  • Health-related quality of life (HRQoL) assessed by EORTC QTQ-30 [ Time Frame: At screening or baseline up to 4 years, approximately ]
  • Health-related quality of life (HRQoL) assessed by EORTC QTQ-OES18 [ Time Frame: At screening or baseline up to 4 years, approximately ]
  • 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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Chemoradiotherapy in Participant With ESCC
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Squamous Cell Carcinoma (ESCC)
Intervention  ICMJE
  • Drug: Tislelizumab
    Administrated at dose of 200 mg intravenously (IV)
    Other Name: BGB-A317
  • Drug: Placebo
    Placebo to match tislelizumab
  • Drug: Paclitaxel
    Administered as 135 mg/m² IV injection
  • Drug: Cisplatin
    Administered as 25 mg/m² IV injection
  • Radiation: Radiotherapy
    Administered at a total dose of 50.4 Gy in 28 fractions
Study Arms  ICMJE
  • Experimental: Tislelizumab + chemoradiotherapy
    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
    Interventions:
    • Drug: Tislelizumab
    • Drug: Paclitaxel
    • Drug: Cisplatin
    • Radiation: Radiotherapy
  • Placebo Comparator: Placebo combined + chemoradiotherapy
    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
    Interventions:
    • Drug: Placebo
    • Drug: Paclitaxel
    • Drug: Cisplatin
    • Radiation: Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019) 		316
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2023
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957590
Other Study ID Numbers  ICMJE BGB-A317-311
CTR20190198 ( Registry Identifier: Center for drug evaluation, CFDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Weihu Wang, MD Beijing Cancer Hospital
Principal Investigator: Zefen Xiao, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
PRS Account BeiGene
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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