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

Esophageal Squamous Cell Carcinoma (ESCC) Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03783442
• Other study ID #: BGB-A317-306
• Secondary ID: 2018-000587-28CT
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 11, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 649
• Est. completion date: June 30, 2024
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Esophageal Squamous Cell Carcinoma (ESCC)

Intervention

Drug:
• Cisplatin
Administered IV
• Oxaliplatin
Administered IV
• Fluorouracil (5-FU)
Administered IV
• Capecitabine
Administered orally
• Paclitaxel
Administered IV
• Tislelizumab
Administered IV
• Placebo
Placebo to match Tislelizumab

Locations

Country	Name	City	State
Australia	Coffs Harbour Hospital	Coffs Harbour	Pacific Highway
Australia	Townsville Hospital	Douglas	Queensland
Australia	St Vincent's Hospital	Fitzroy	Victoria
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Ashford Cancer Centre Research	Kurralta Park	South Australia
Australia	Ballarat Oncology & Haematology Services	Wendouree	Victoria
Belgium	Institut Jules Bordet - Oncologie Médicale	Anderlecht	Brussels Capital Region
Belgium	AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology	Brugge	West-Vlaanderen
Belgium	Grand Hôpital de Charleroi - Site Notre-Dame	Charleroi	Hainaut
Belgium	Antwerp University Hospital	Edegem	Antwerpen
Belgium	UZ Gent - Radiologie	Gent	Oost-Vlaanderen
Belgium	UZ Leuven - Campus Gasthuisberg	Leuven	Vlaams Brabant
Belgium	CHC Mont Legia	Liège
Belgium	CHU Liège Sart Tilman	Liège
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Friendship Hospital - Oncology	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital - Oncology	Beijing	Beijing
China	The Fifth Medical Center of Chinese PLA General Hospital	Beijing	Beijing
China	Hunan Cancer Hospital - GCP Office	Changsha	Hunan
China	The First People's Hospital of Changzhou - Oncology	Changzhou	Jiangsu
China	Fujian Provincial Cancer Hospital - Oncology	Fuzhou	Fujian
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Guangdong Province Traditional Chinese Medical Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The Sixth Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	Affiliated Tumor Hospital of Harbin Medical University	Haerbin	Heilongjiang
China	Hainan General Hospital - Oncology	Haikou	Hainan
China	Sir Run Run Shaw Hospital, Zhejiang University	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Anhui Medical University - The Second Hospital	Hefei	Anhui
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	Anhui Provincial Hospital - Oncology	Hefei
China	The Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The First Affiliated Hospital of Zhengzhou University - Oncology	Henan	Henan
China	Shandong Cancer Hospital and Institute, Shandong First Medical University	Jinan	Shandong
China	Linyi Cancer Hospital	Linyi	Shandong
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Cancer Hospital of Guangxi Medical University	Nanning	Guangxi
China	Nantong Cancer Hospital	Nantong	Jiangsu
China	Quanzhou First Hospital - Radiotherapy/Nuclear Medicine	Quanzhou	Quanzhou
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Cancer Hospital of Shantou University Medical College	Shantou	Guangdong
China	Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology	Shenyang	Liaoning
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	WeiFang People's Hospital	Weifang	Shandong
China	Hubei Cancer Hospital - Oncology	Wuhan	Hubei
China	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu
China	The First Affiliated Hospital of Xiamen University - Oncology	Xiamen
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	Xiangyang Central Hospital	Xiangyang	Hubei
China	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	The Affiliated Hospital of Xuzhou Medical University - Radiology	Xuzhou	Jiangsu
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	Henan Cancer Hospital - Oncology	Zhengzhou	Henan
Czechia	Fakultní Nemocnice Olomouc	Olomouc
Czechia	Thomayerova nemocnice	Praha 4
Czechia	Nemocnice Na Bulovce	Praha 8
France	CHRU de Besançon- Hôpital Jean Minjoz	Besançon Cedex	Doubs
France	Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie	Brest Cedex	Bretagne
France	Institut Hospitalier Franco-Britannique (IHFB) - Levallois-Perret - 4 Rue Kleber	Levallois-Perret	Hauts-de-Seine
France	Center Oscar Lambret - Alliance Member	Lille	Nord
France	Centre Léon Bérard	Lyon	Rhône
France	Groupe Hospitalier Paris Saint Joseph - Oncologie	Paris
France	Hopital Europeen Georges Pompidou - Digestive Oncology	Paris
France	Hopital Saint-Antoine / Service d'Hepato-Gastro-Enterologie	Paris Cedex 12	Paris
France	CHU Bordeaux Hôpital Du Haut-Lévêque	Pessac Cedex	Gironde
France	Centre Hospitalier Universitaire de Poitiers	Poitiers	Vienne
France	ICO	Saint-Herblain	Loire-Atlantique
Germany	University Hospital Hamburg- Eppendorf	Hamburg
Germany	SLK Kliniken Heilbronn GmbH - Klinik für Radiologie, Minimalinvasive Therapien und Nuklearmedizin	Heilbronn	Baden-Württemberg
Germany	University Hospital Of Leipzig	Leipzig	Sachsen
Germany	Universitätsmedizin Mainz	Mainz	Rheinland-Pfalz
Germany	Johannes Wesling Klinikum Minden	Minden	Nordrhein-Westfalen
Germany	University Hospital Tuebingen	Tuebingen	Baden-Württemberg
Italy	Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica	Ancona
Italy	Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori', IRCCS - Laboratorio	Meldola	Emilia-Romagna
Italy	Asst Grande Ospedale Metropolitano Niguarda	Milano
Italy	Ieo, Irccs	Milano
Italy	Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori	Napoli
Italy	Istituto Oncologico Veneto IOV-IRCCS	Padova
Italy	SO S.Chiara, AOU Pisana - Oncologia 2	Pisa
Italy	Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica	Torino	Ancona
Japan	Hyogo Cancer Center	Akashi
Japan	Akita University Hospital - Pediatrics	Akita-shi
Japan	Kansai Rosai Hospital - Gastroenterological Surgery	Amagasaki
Japan	National Cancer Center Hospital - Gastrointestinal Oncology	Chuo Ku	Tokyo
Japan	Kyushu Medical Center - Gastroenterological Surgery	Fukuoka	Hukuoka
Japan	National Hospital Organization Kyushu Cancer Center - GI and Medical Oncology	Fukuoka	Hukuoka
Japan	Hiroshima University Hospital - Gastrointestinal Surgery	Hiroshima
Japan	Kindai University Nara Hospital	Ikoma	Osaka
Japan	University Hospital, Kyoto Prefectural Univ of Medicine - Gastroenterology	Kamigyo-ku	Kyoto
Japan	National Cancer Center Hospital East - Gastrointestinal Oncology	Kashiwa	Chiba
Japan	Kagawa University Hospital - Oncology	Kita-gun	Kagawa
Japan	Kobe City Medical Center General Hospital - Medical Oncology	Kobe	Hyogo
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kyoto University Hospital	Kyoto
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Osaka International Cancer Institute - Clinical Oncology	Osaka
Japan	Saitama Cancer Center - Gastroenterology	Saitama
Japan	Osaka University Hospital - Medical Oncology	Suita	Osaka
Japan	Kanagawa Cancer Center - Gastroenterological surgery	Yokohama	Kanagawa
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chonnam National University Hwasun Hospital - Hematology and Oncology Clinic	Hwasun	Jeonranamdo [Chollanam-do]
Korea, Republic of	Gachon University Gil Medical Center - Oncology	Incheon	Incheon Gwang'yeogsi [Inch'n-K
Korea, Republic of	CHA Bundang Medical Center, CHA University - Oncology	Seongnam-si	Gyeonggido
Korea, Republic of	Seoul National University Bundang Hospital - Hematology/Oncology	Seongnam-si	Gyeonggido [Kyonggi-do]
Korea, Republic of	Asan Medical Center - Oncology	Seoul
Korea, Republic of	Korea University Guro Hospital - Hematology-Oncology	Seoul	Seoul Teugbyeolsi [Seoul-T'ukp
Korea, Republic of	Samsung Medical Center - Hematology-Oncology	Seoul	Seoul Teugbyeolsi [Seoul-T'ukp
Korea, Republic of	SMG-SNU Boramae Medical Center - Oncology	Seoul	Seoul Teugbyeolsi [Seoul-T'ukp
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul	Seoul Teugbyeolsi [Seoul-T'ukp]
Poland	Szpital Specjalist. w Brzozowie,Podkarpacki Osrodek Onkologi	Brzozow	Podkarpackie
Poland	Szpital Wojewodzki w Koszalinie	Koszalin	Pomorskie
Poland	SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii	Olsztyn	Warminsko-mazurskie
Poland	Clinical Research Center Sp. z o.o., Medic-R Sp. K.	Poznan	Wielkopolskie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy	Warszawa	Mazowieckie
Romania	Institutul Clinic Fundeni	Bucuresti
Romania	Spitalul Clinic Coltea	Bucuresti
Romania	Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca	Cluj-Napoca	Cluj
Romania	Medisprof	Cluj-Napoca
Romania	Centrul de Oncologie Sf. Nectarie	Craiova	Dolj
Romania	Radiotherapy Center Cluj	Floresti	Cluj
Romania	Centrul de Oncologie Euroclinic	Iasi
Russian Federation	Arkhangelsk Regional Clinical Oncological Dispensary	Arkhangelsk	Arkhangel'skaya Oblast'
Russian Federation	Ivanovo Regional Oncology Dispensary	Ivanovo
Russian Federation	Leningrad Regional Oncology Dispensary	Kuz'molovskiy	Leningradskaya Oblast
Russian Federation	Orenburg Regional Clinical Oncology Center	Orenburg	Orenburgskaya Oblast
Russian Federation	Rostov Research Institute of Oncology (RRIO)	Rostov-Na-Donu	Rostovskaya Oblast
Russian Federation	City Oncology Dispensary	Saint Petersburg	Sankt-Peterburg
Russian Federation	Petrov Research Institute of Oncology	Saint Petersburg
Russian Federation	The First Saint-Petersburg State Medical University named after Academician I.P. Pavlov	Saint Petersburg	Sankt-Peterburg
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitario Vall d'Hebrón	Barcelona
Spain	Institut Catalá d´Oncología (I.C.O.)	L'Hospitalet De Llobregat	Barcelona
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario Virgen De La Victoria	Málaga
Spain	H.U.V.Arrixaca	Murcia
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Madrid Norte Sanchinarro	Sanchinarro	Madrid
Spain	Hospital Universitario Miguel Servet	Zaragoza
Taiwan	Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital - Thoracic Surgery	Kaohsiung
Taiwan	China Medical University Hospital - Oncology - Taichung	Taichung
Taiwan	Chi Mei Hospital, Liouying - Department of Oncology	Tainan
Taiwan	Chi Mei Medical Center - YongKang - Chi Mei Medical Center	Tainan
United Kingdom	Beatson West of Scotland Cancer Centre - Oncology	Glasgow	Scotland
United Kingdom	Guys and St Thomas' Hospital	London	City Of London
United Kingdom	Royal Marsden NHS Foundation Trust Sutton	London	City Of London
United Kingdom	The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital	London	City Of London
United Kingdom	Maidstone and Tunbridge Wells NHS Trust - Kent Oncology Centre	Maidstone	Kent
United Kingdom	The Christie NHS Foundation Trust - Oak Road Treatment Centr	Manchester
United Kingdom	Mount Vernon Cancer Centre	Northwood	England
United States	Medical University of South Carolina Hollings Cancer Center	Charleston	South Carolina
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Smilow Cancer Hospital at Yale-New Haven - Neurology	New Haven	Connecticut
United States	Allegheny General Hospital (AGH)	Pittsburgh	Pennsylvania
United States	University of Texas Health Science Center of San Antonio	San Antonio	Texas
United States	Renovatio Clinical	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  China,  Czechia,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Poland,  Romania,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

References & Publications (1)

Xu J, Kato K, Raymond E, Hubner RA, Shu Y, Pan Y, Park SR, Ping L, Jiang Y, Zhang J, Wu X, Yao Y, Shen L, Kojima T, Gotovkin E, Ishihara R, Wyrwicz L, Van Cutsem E, Jimenez-Fonseca P, Lin CY, Wang L, Shi J, Li L, Yoon HH. Tislelizumab plus chemotherapy ve — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS is defined as the time from the date of randomization until the date of death due to any cause	Up to approximately 3 years and 2 months (as of primary analysis data cut-off date of 28FEB2022)
Secondary	Progression-Free Survival (PFS)	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	Approximately 40 months from date of the first participant randomization
Secondary	Objective Response Rate (ORR)	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	Approximately 40 months from date of the first participant randomization
Secondary	Overall Survival (OS) in the PD-L1 Score = 10% Subgroup	OS is defined as the time from the date of randomization until the date of death due to any cause	Approximately 40 months from date of the first participant randomization
Secondary	Duration of Response (DOR)	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	Approximately 40 months from date of the first participant randomization
Secondary	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)		Approximately 40 months from date of the first participant randomization
Secondary	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)		Approximately 40 months from date of the first participant randomization
Secondary	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)		Approximately 40 months from date of the first participant randomization
Secondary	Number of Participants Experiencing Adverse Events (AEs)		Approximately 40 months from date of the first participant randomization