The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03783442
Recruitment Status : Active, not recruiting
First Posted : December 21, 2018
Results First Posted : November 7, 2023
Last Update Posted : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma (ESCC) Drug: Cisplatin Drug: Oxaliplatin Drug: Fluorouracil (5-FU) Drug: Capecitabine Drug: Paclitaxel Drug: Tislelizumab Drug: Placebo Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 649 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Actual Study Start Date : December 11, 2018
Actual Primary Completion Date : February 28, 2022
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Tislelizumab + Chemotherapy

Tislelizumab 200 milligrams (mg) administered intravenously (IV) on Day 1 of each cycle every 3 weeks (Q3W) plus one of the following until unacceptable toxicity, disease progression or withdrawal for other reasons; each cycle is 21 days

  • Chemotherapy Doublet A: cisplatin 60-80 mg/m^2 or oxaliplatin 130 mg/m^2 administered IV on Day 1 of each cycle Q3W and 5-fluorouracil IV 750-800 mg/m^2 on Days 1 to 5 of each cycle Q3W;
  • Chemotherapy Doublet B: cisplatin 60-80 mg/m^2 or oxaliplatin 130 mg/m^2 administered IV on Day 1 of each cycle Q3W and capecitabine orally 1000 mg/m^2 on Days 1 to 14 of each cycle, twice a day; or
  • Chemotherapy Doublet C: cisplatin 60-80 mg/m^2 administered IV on Day 1 or 2 or oxaliplatin 130 mg/m^2 administered IV on Day 1 of each cycle Q3W and paclitaxel 175 mg/m^2 IV on Day 1 of each cycle Q3W; cisplatin may be given in 3 divided doses on Days 1, 2, and 3 depending on local guidelines
 Drug: Cisplatin
Administered IV

Drug: Oxaliplatin
Administered IV

Drug: Fluorouracil (5-FU)
Administered IV

Drug: Capecitabine
Administered orally

Drug: Paclitaxel
Administered IV

Drug: Tislelizumab
Administered IV
Other Name: BGB-A317
Active Comparator: Placebo + Chemotherapy

Matched placebo administered IV on Day 1 of each cycle every 3 weeks (Q3W) plus one of the following until unacceptable toxicity, disease progression or withdrawal for other reasons; each cycle is 21 days

  • Chemotherapy Doublet A: cisplatin 60-80 mg/m^2 or oxaliplatin 130 mg/m^2 administered IV on Day 1 of each cycle Q3W and 5-fluorouracil IV 750-800 mg/m^2 on Days 1 to 5 of each cycle Q3W;
  • Chemotherapy Doublet B: cisplatin 60-80 mg/m^2 or oxaliplatin 130 mg/m^2 administered IV on Day 1 of each cycle Q3W and capecitabine orally 1000 mg/m^2 on Days 1 to 14 of each cycle, twice a day; or

Chemotherapy Doublet C: cisplatin 60-80 mg/m^2 administered IV on Day 1 or 2 or oxaliplatin 130 mg/m^2 administered IV on Day 1 of each cycle Q3W and paclitaxel 175 mg/m^2 IV on Day 1 of each cycle Q3W; cisplatin may be given in 3 divided doses on Days 1, 2, and 3 depending on local guidelines

 Drug: Cisplatin
Administered IV

Drug: Oxaliplatin
Administered IV

Drug: Fluorouracil (5-FU)
Administered IV

Drug: Capecitabine
Administered orally

Drug: Paclitaxel
Administered IV

Drug: Placebo
Placebo to match Tislelizumab


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 3 years and 2 months (as of primary analysis data cut-off date of 28FEB2022) ]
    OS is defined as the time from the date of randomization until the date of death due to any cause


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
    PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first

  2. Objective Response Rate (ORR) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
    ORR is defined as the proportion of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by the investigator per RECIST v1.1

  3. Overall Survival (OS) in the PD-L1 Score ≥ 10% Subgroup [ Time Frame: Approximately 40 months from date of the first participant randomization ]
    OS is defined as the time from the date of randomization until the date of death due to any cause

  4. Duration of Response (DOR) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
    DOR is defined as the time from the first determination of an objective response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever comes first

  5. Health-Related Quality of Life (HRQoL) Assessment of the Participant's Overall Health Status Using European Quality of Life-Core 30 Questionnaire Index (EORTC QLQ-C30) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
  6. Health-Related Quality of Life (HRQoL) Assessment of the Participant's Overall Health Status Using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Esophageal Cancer Specific Module (EORTC QLQ-OES18) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
  7. Health-Related Quality of Life (HRQoL) Assessment of the Participant's Overall Health Status Using the Generic Health State Instrument European Quality of Life-5 Dimensions (EuroQol 5D EQ-5D-5L) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
  8. Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Approximately 40 months from date of the first participant randomization ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Pathologically (histologically) confirmed diagnosis of ESCC
  2. Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced recurrent or metastatic disease (per American Joint Committee on Cancer 7th Edition), if there is prior neoadjuvant/adjuvant therapy with platinum-based chemotherapy, a treatment-free interval of at least 6 months is required.

Key Exclusion Criteria:

  1. Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation
  2. Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC
  3. Received prior therapies targeting programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1) or PD-L2
  4. Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta)
  5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (clinically significant recurrence requiring an additional intervention within 2 weeks of intervention)
  6. Evidence of complete esophageal obstruction not amenable to treatment
  7. Unintentional weight loss ≥ 5% within one month prior to randomization or Nutritional Risk Index (NRI) < 83.5 per investigator's choice
  8. Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator.
  9. Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is ≥ 500 IU/mL or participants with active hepatitis C virus (HCV)

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783442


Locations
Show Show 162 study locations
Sponsors and Collaborators
BeiGene
Investigators
Layout table for investigator information
Study Director: Study Director BeiGene
  Study Documents (Full-Text)

Documents provided by BeiGene:
Study Protocol  [PDF] April 30, 2021
Statistical Analysis Plan  [PDF] February 18, 2022

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03783442    
Other Study ID Numbers: BGB-A317-306
2018-000587-28 ( EudraCT Number )
CTR20181013 ( Other Identifier: Center for drug evaluation, CFDA )
JapicCTI-194741 ( Registry Identifier: Japic )
First Posted: December 21, 2018    Key Record Dates
Results First Posted: November 7, 2023
Last Update Posted: April 17, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
 Paclitaxel
Capecitabine
Oxaliplatin
Fluorouracil
Tislelizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors