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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03783442




Registration number
NCT03783442
Ethics application status
Date submitted
18/12/2018
Date registered
21/12/2018
Date last updated
12/08/2019

Titles & IDs
Public title
A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Patients With Advanced Esophageal Squamous Cell Carcinoma
Scientific 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
Secondary ID [1] 0 0
2018-000587-28
Secondary ID [2] 0 0
BGB-A317-306
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Esophageal Squamous Cell Carcinoma (ESCC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Platinum (cisplatin or oxaliplatin) + Fluorouracil (5-FU)
Treatment: Drugs - Platinum (cisplatin or oxaliplatin) + capecitabine
Treatment: Drugs - Platinum (cisplatin or oxaliplatin) + paclitaxel

Experimental: Arm A - Tislelizumab + chemotherapy

Active Comparator: Arm B - Placebo + chemotherapy


Treatment: Drugs: Platinum (cisplatin or oxaliplatin) + Fluorouracil (5-FU)
Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 Q3W
5-FU 750 to 800 mg/m2 IV continuous infusion over 24 hours daily on Days 1 to 5 Q3W

Treatment: Drugs: Platinum (cisplatin or oxaliplatin) + capecitabine
Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 Q3W
Capecitabine 1000 mg/m2 orally (PO) twice daily (BID) on Days 1 to 14 Q3W

Treatment: Drugs: Platinum (cisplatin or oxaliplatin) + paclitaxel
Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 or 2 Q3W
Depending on local guidelines, cisplatin may be given in 3 divided doses on Days 1, 2, and 3. The total dose given must be between 60 to 80 mg/m2 per cycle.
Paclitaxel 175 mg/m2 IV on Day 1 Q3W

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PFS - defined as the time from the date of randomization to the date of first documentation of disease progression assessed by BIRC per RECIST v1.1 or death, whichever occurs first
Timepoint [1] 0 0
Approximately 31 months from date of the first patient randomization
Primary outcome [2] 0 0
OS - defined as the time from the date of randomization until the date of death due to any cause
Timepoint [2] 0 0
Approximately 31 months from date of the first patient randomization

Eligibility
Key inclusion criteria
Patients with unresectable, locally advanced recurrent or metastatic ESCC who have Stage IV
unresectable ESCC at first diagnosis (ie, Stage IV disease at the original diagnosis of
ESCC) or who have unresectable, locally advanced recurrent or metastatic disease with at
least a 6-month treatment-free interval, if prior definitive therapy (chemotherapy,
chemo-radiation therapy or surgery) was given.



1. Pathologically (histologically) confirmed diagnosis of ESCC

2. Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced
recurrent or metastatic disease with a treatment free interval of at least 6 months
after definitive treatment.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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 PD-1, PD-L1 or PD-L2

4. Patients 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 other
indicators of severe malnutrition (Severe malnutrition may be determined using the
Nutritional Risk Index (Shirasu, et al. 2018))

8. Patients receiving chemotherapy doublet C (platinum and paclitaxel) must not have
peripheral neuropathy = Grade 2 at baseline

9. Patients who recur after definitive surgery and are eligible for non-palliative
radiation therapy and/or chemoradiotherapy.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Pacific HighwayQLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Coffs Harbour Hospital - Coffs Harbour
Recruitment hospital [2] 0 0
Townsville Hospital - Douglas
Recruitment hospital [3] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [4] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [6] 0 0
Ballarat Oncology & Haematology Services - Wendouree
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment postcode(s) [3] 0 0
6008 - Kurralta Park
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3355 - Wendouree
Recruitment outside Australia
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United States of America
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Connecticut
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Michigan
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Pennsylvania
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South Carolina
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Texas
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Belgium
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Antwerpen
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Belgium
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Brussels Capital Region
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Belgium
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Hainaut
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Belgium
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Oost-Vlaanderen
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Belgium
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Vlaams Brabant
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Belgium
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West-Vlaanderen
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Belgium
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Liège
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China
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Anhui
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China
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Beijing
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China
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Fujian
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China
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Guangdong
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China
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Guangxi
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China
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Guangzhou
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China
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Hainan
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China
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Heilongjiang
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China
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Henan
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China
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Hubei
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China
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Hunan
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Jiangsu
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Jiangxi
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Liaoning
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Quanzhou
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Shandong
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Shanghai
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China
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Shanxi
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China
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Tianjin
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China
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Zhejiang
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China
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Changsha
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China
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Haikou Shi
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China
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Hefei
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China
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Nanjing
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China
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Xiamen
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Czechia
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Olomouc
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Czechia
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Praha 4
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Czechia
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Praha 8
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Bretagne
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Nord
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Paris
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Rhône
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Vienne
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Germany
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Baden-Württemberg
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Nordrhein-Westfalen
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Germany
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Saarland
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Hamburg
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Ancona
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Meldola
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Milano
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Napoli
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Padova
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Pisa
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Torino
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Chiba
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Hukuoka
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Hyogo
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Saitama
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Tokyo
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Akashi
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Akita-shi
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Amagasaki
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Hiroshima
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Kumamoto
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Kyoto
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Cluj-Napoca
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Iasi
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Arkhangel'skaya Oblast'
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Russian Federation
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Leningradskaya Oblast
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Russian Federation
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Orenburgskaya Oblast
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Rostovskaya Oblast
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Russian Federation
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Sankt-Peterburg
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Ivanovo
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Zaragoza
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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United Kingdom
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City Of London
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United Kingdom
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England
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United Kingdom
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Scotland
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Kent
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Leeds
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
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 patients with advanced
unresectable/metastatic ESCC.
Trial website
https://clinicaltrials.gov/show/NCT03783442
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Virginia Paton, Europe and United States
Address 0 0
Country 0 0
Phone 0 0
1 (877) 828-5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03783442