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

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ClinicalTrials.gov Identifier: NCT03957590
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

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

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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

Resource links provided by the National Library of Medicine


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




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. ]


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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.


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): NCT03957590


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

Locations
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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
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03957590    
Other Study ID Numbers: BGB-A317-311
CTR20190198 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action