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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03783442
Ethics application status
Date submitted
18/12/2018
Date registered
21/12/2018

Titles & IDs
Public title
A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants 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 - Cisplatin
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Fluorouracil (5-FU)
Treatment: Drugs - Capecitabine
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Tislelizumab
Treatment: Drugs - Placebo

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

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


Treatment: Drugs: Cisplatin
Administered IV

Treatment: Drugs: Oxaliplatin
Administered IV

Treatment: Drugs: Fluorouracil (5-FU)
Administered IV

Treatment: Drugs: Capecitabine
Administered orally

Treatment: Drugs: Paclitaxel
Administered IV

Treatment: Drugs: Tislelizumab
Administered IV

Treatment: Drugs: Placebo
Placebo to match Tislelizumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 3 years and 2 months (as of primary analysis data cut-off date of 28FEB2022)
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Approximately 40 months from date of the first participant randomization
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Approximately 40 months from date of the first participant randomization
Secondary outcome [3] 0 0
Overall Survival (OS) in the PD-L1 Score = 10% Subgroup
Timepoint [3] 0 0
Approximately 40 months from date of the first participant randomization
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
Approximately 40 months from date of the first participant randomization
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
Approximately 40 months from date of the first participant randomization
Secondary outcome [6] 0 0
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)
Timepoint [6] 0 0
Approximately 40 months from date of the first participant randomization
Secondary outcome [7] 0 0
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)
Timepoint [7] 0 0
Approximately 40 months from date of the first participant randomization
Secondary outcome [8] 0 0
Number of Participants Experiencing Adverse Events (AEs)
Timepoint [8] 0 0
Approximately 40 months from date of the first participant randomization

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
No limit
Sex
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 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.

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


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/08/2024
Sample size
Target
Accrual to date
Final
649
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [2] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Belgium
State/province [3] 0 0
Anderlecht
Country [4] 0 0
Belgium
State/province [4] 0 0
Brugge
Country [5] 0 0
Belgium
State/province [5] 0 0
Charleroi
Country [6] 0 0
Belgium
State/province [6] 0 0
Gent
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Belgium
State/province [8] 0 0
Liege
Country [9] 0 0
China
State/province [9] 0 0
Anhui
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Fujian
Country [12] 0 0
China
State/province [12] 0 0
Guangdong
Country [13] 0 0
China
State/province [13] 0 0
Guangxi
Country [14] 0 0
China
State/province [14] 0 0
Hainan
Country [15] 0 0
China
State/province [15] 0 0
Heilongjiang
Country [16] 0 0
China
State/province [16] 0 0
Henan
Country [17] 0 0
China
State/province [17] 0 0
Hubei
Country [18] 0 0
China
State/province [18] 0 0
Hunan
Country [19] 0 0
China
State/province [19] 0 0
Jiangsu
Country [20] 0 0
China
State/province [20] 0 0
Jiangxi
Country [21] 0 0
China
State/province [21] 0 0
Liaoning
Country [22] 0 0
China
State/province [22] 0 0
Shandong
Country [23] 0 0
China
State/province [23] 0 0
Shanghai
Country [24] 0 0
China
State/province [24] 0 0
Shanxi
Country [25] 0 0
China
State/province [25] 0 0
Tianjin
Country [26] 0 0
China
State/province [26] 0 0
Zhejiang
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha
Country [28] 0 0
France
State/province [28] 0 0
Brest
Country [29] 0 0
France
State/province [29] 0 0
Doubs
Country [30] 0 0
France
State/province [30] 0 0
LevalloisPerret
Country [31] 0 0
France
State/province [31] 0 0
Lille
Country [32] 0 0
France
State/province [32] 0 0
Lyon Cedex
Country [33] 0 0
France
State/province [33] 0 0
Paris Cedex
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Pessac
Country [36] 0 0
France
State/province [36] 0 0
Poitiers
Country [37] 0 0
France
State/province [37] 0 0
SaintHerblain
Country [38] 0 0
Germany
State/province [38] 0 0
Hamburg
Country [39] 0 0
Germany
State/province [39] 0 0
Heilbronn
Country [40] 0 0
Germany
State/province [40] 0 0
Leipzig
Country [41] 0 0
Italy
State/province [41] 0 0
Meldola
Country [42] 0 0
Italy
State/province [42] 0 0
Milano
Country [43] 0 0
Italy
State/province [43] 0 0
Napoli
Country [44] 0 0
Italy
State/province [44] 0 0
Padova
Country [45] 0 0
Italy
State/province [45] 0 0
Torrette
Country [46] 0 0
Japan
State/province [46] 0 0
Akita
Country [47] 0 0
Japan
State/province [47] 0 0
Chiba
Country [48] 0 0
Japan
State/province [48] 0 0
Fukuoka
Country [49] 0 0
Japan
State/province [49] 0 0
Hyogo
Country [50] 0 0
Japan
State/province [50] 0 0
Kanagawa
Country [51] 0 0
Japan
State/province [51] 0 0
Osaka
Country [52] 0 0
Japan
State/province [52] 0 0
Saitama
Country [53] 0 0
Japan
State/province [53] 0 0
Tokyo
Country [54] 0 0
Japan
State/province [54] 0 0
Hiroshima
Country [55] 0 0
Japan
State/province [55] 0 0
Kumamoto
Country [56] 0 0
Japan
State/province [56] 0 0
Kyoto
Country [57] 0 0
Japan
State/province [57] 0 0
Niigata
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Daegu Gwang'yeogsi
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Gyeonggi-do
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Incheon Gwang'yeogsi
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Jeollanam-do
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Seoul Teugbyeolsi
Country [63] 0 0
Poland
State/province [63] 0 0
Brzozow
Country [64] 0 0
Poland
State/province [64] 0 0
Koszalin
Country [65] 0 0
Poland
State/province [65] 0 0
Olsztyn
Country [66] 0 0
Poland
State/province [66] 0 0
Warszawa
Country [67] 0 0
Romania
State/province [67] 0 0
ClujNapoca
Country [68] 0 0
Romania
State/province [68] 0 0
Craiova
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Arkhangel'skaya Oblast'
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Ivanovskaya Oblast'
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Leningradskaya Oblast'
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Orenburgskaya Oblast'
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Rostovskaya Oblast'
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Sankt-Peterburg
Country [75] 0 0
Russian Federation
State/province [75] 0 0
SaintPetersburg
Country [76] 0 0
Spain
State/province [76] 0 0
Barcelona
Country [77] 0 0
Spain
State/province [77] 0 0
Madrid
Country [78] 0 0
Spain
State/province [78] 0 0
Malaga
Country [79] 0 0
Spain
State/province [79] 0 0
Oviedo
Country [80] 0 0
Spain
State/province [80] 0 0
Zaragoza
Country [81] 0 0
Taiwan
State/province [81] 0 0
Chiayi
Country [82] 0 0
Taiwan
State/province [82] 0 0
Taichung
Country [83] 0 0
Taiwan
State/province [83] 0 0
Tainan
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Greater Manchester
Country [85] 0 0
United Kingdom
State/province [85] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Xu J, Kato K, Raymond E, Hubner RA, Shu Y, Pan Y, ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT03783442