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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03957590
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : November 4, 2019
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 Patients with Localized Esophageal Squamous Cell Carcinoma.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma (ESCC) Drug: Tislelizumab(BGB-A317 combined with chemoradiotherapy. Drug: Placebo combined with chemoradiotherapy 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: Arm A: Tislelizumab (BGB-A317)combined with chemoradiotherapy
Tislelizumab(BGB-A317) will be administrated at dose of 200 mg intravenous dosing (IV) once every cycle (Q3W), Paclitaxel 135 mg/m² will be administered as an intravenous infusion on Day 1 of every cycle (3 weeks), total 2 Cycle; Cisplatin 25 mg/m² will be administered as an intravenous infusion on Day 1 to 3 of every cycle (3 weeks) Total 2 Cycle. Radiotherapy total dose of 50.4 Gy in 28 fractions
Drug: Tislelizumab(BGB-A317 combined with chemoradiotherapy.
Tislelizumab with concurrent chemoradiotherapy

Placebo Comparator: Arm B: Placebo combined with chemoradiotherapy
Placebo will be administrated at does of 200 mg intravenous dosing (IV)once every cycle (Q3W); Paclitaxel 135 mg/m² will be administered as an intravenous infusion on Day 1 of every cycle (3 weeks) , total 2 Cycle; Cisplatin 25 mg/m² will be administered as an intravenous infusion on Day 1 to 3 of every cycle (3 weeks), total 2 Cycle. Radiotherapy total dose of 50.4 Gy in 28 fractions.
Drug: Placebo combined with chemoradiotherapy
Placebo with concurrent chemoradiotherapy




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 dysponoea, 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. ]


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.


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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

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
  • ECOG Performance Status ≤ 1
  • Adequate organ function

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

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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China, Beijing
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
China, Fujian
Fujian Cancer Hospital Not yet recruiting
Fuzhou, Fujian, China, 350014
China, Jiangsu
Northern Jiangsu people's hospital Not yet recruiting
Yangzhou, Jiangsu, China, 225001
China, Shanghai
Fudan University Shanghai Cancer Center Not yet recruiting
Shanghai, Shanghai, China, 200032
China, Sichuan
Sichuan Cancer hospital Recruiting
Chengdu, Sichuan, China, 610041
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: November 4, 2019
Last Verified: September 2019

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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