Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

PHASE3CompletedINTERVENTIONAL
Enrollment

997

Participants

Timeline

Start Date

December 13, 2018

Primary Completion Date

February 28, 2023

Study Completion Date

August 27, 2024

Conditions
Gastric, or Gastroesophageal Junction Adenocarcinoma
Interventions
DRUG

Tislelizumab

200 mg intravenously (IV) on Day 1 of each 21-day cycle

DRUG

Placebo

Placebo to match tislelizumab IV on Day 1 of each 21-day cycle

DRUG

Cisplatin

80 mg/m² IV on Day 1 of each 21-day cycle

DRUG

Oxaliplatin

130 mg/m² IV on Day 1 of each 21-day cycle

DRUG

Capecitabine

1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) of each 21-day cycle

DRUG

5-Fluorouracil

800 mg/m²/day IV using continuous infusion on Days 1 to 5 of each 21-day cycle

Trial Locations (149)

133

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Roma

704

National Cheng Kung University Hospital, Tainan City

807

Kaohsiung Medical University Chung Ho Memorial Hospital, Kaohsiung City

3203

Hospital General Universitario de Elche, Elche

6973

Chung Ang University Hospital, Seoul

8036

Hospital Clinic de Barcelona, Barcelona

10126

Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino, Torino

10408

National Cancer Center, Goyang-si

11217

Taipei Veterans General Hospital, Taipei

13005

Hopital de La Timone, Marseille

13620

Seoul National University Bundang Hospital, Seongnam-si

16247

The Catholic University of Korea, St Vincents Hospital, Suwon

16499

Ajou University Hospital, Suwon

19111

Fox Chase Cancer Center, Philadelphia

19611

Reading Hospital, West Reading

20133

Fondazione Irccs Istituto Nazionale Dei Tumori, Milan

21079

Centre Georges Francois Leclerc, Dijon

21080

Dicle University Medical Faculty, Diyarbakır

25030

Chu Besancon Hopital Jean Minjoz, Doubs

25200

Hopital Nord Franche Comte Site Du Mittan, Montbéliard

28007

Hospital General Universitario Gregorio Maranon, Madrid

28046

Hospital Universitario La Paz, Madrid

28050

Hospital Universitario Hm Madrid Sanchinarro, Madrid

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

29010

Hospital Regional Universitario de Malaga, Málaga

30265

Southeastern Regional Medical Center, Newnan

31008

Complejo Hospitalario de Navarra, Pamplona

33600

Chu Bordeaux Hopital Haut Leveque, Pessac

34098

Iu C, Clinical Research Excellence Application and Research Center, Stanbul

35128

Iov Istituto Oncologico Veneto Irccs, Padua

37203

Tennessee Oncology, Pllc Nashville, Nashville

40138

Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi, Bologna

41013

Hospital Universitario Virgen Del Rocio, Seville

41404

Kyungpook National University Chilgok Hospital, Daegu

43210

Ohio State University Hospital, Columbus

44280

Nonu Universitesi Tip Fakultesi, Battalgazi

46010

Hospital Clinico Universitario de Valencia, Valencia

Initia Oncologia, Slp, Valencia

48013

Hospital de Basurto, Bilbao

50009

Hospital Universitario Miguel Servet, Zaragoza

53100

Aou Senese Policlinico Santa Maria Alle Scotte, Siena

54519

Icl Alexis Vautrin, Meurthe Et Moselle

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

58128

Chonnam National University Hwasun Hospital, HwasunGun

59100

Namik Kemal University, Tekirdağ

60020

Azienda Ospedaliera Universitaria Delle Marche, Torrette

61080

Karadeniz Tecnical Uni Med Fac, Trabzon

61122

Ao Ospedali Riuniti Marche Nord, Pesaro

71013

Irccs Ospedale Casa Sollievo Della Sofferenza, San Giovanni Rotondo

80131

Istituto Nazionale Tumori Fondazione G Pascale, Napoli

95817

University of California Davis Health System, Sacramento

100000

Peking University Third Hospital, Beijing

100020

Beijing Chao Yang Hospital, Beijing

100021

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

100050

Beijing Friendship Hospital, Capital Medical University, Beijing

100142

Beijing Cancer Hospital, Beijing

100730

Peking Union Medical College Hospital, Beijing

100853

Chinese Pla General Hospital, Beijing

101149

Beijing Luhe Hospital, Capital Medical University, Beijing

110001

The First Hospital of China Medical University, Shenyang

110016

The General Hospital of Shenyang Military, Shenyang

110042

Liaoning Cancer Hospital and Institute, Shenyang

121309

Vitamed Llc, Moscow

130021

The First Hospital of Jilin University, Changchun

150000

Harbin Medical University Cancer Hospital, Harbin

150054

Sbih of Yaroslavl Region Regional Clinical Oncological Hospital, Yaroslavl

153040

Rbih Ivanovo Regional Oncological Dispensary, Ivanovo

163045

Arkhangelsk Regional Clinical Oncological Dispensary, Arkhangelsk

197022

Pavlov First Saint Petersburg State Medical University, SaintPetersburg

197758

Fsbi Clinical Research and Practical Center For Specialized Medical Care (Oncology), SanktPetersburg

200025

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai

200032

Affiliated Zhongshan Hospital of Fudan University, Shanghai

200080

Shanghai General Hospital, Shanghai

200092

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

210008

Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School, Nanjing

226000

Nantong Tumor Hospital Branch South, Nantong

230088

Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital, Hefei

230601

The Second Hospital of Anhui Medical University, Hefei

233004

The First Affiliated Hospital of Bengbu Medical College, Bengbu

250117

Shandong Cancer Hospital, Jinan

266000

The Affiliated Hospital of Qingdao University Branch South, Qingdao

276001

Linyi Cancer Hospital, Linyi

300052

Tianjin Medical University General Hospital, Tianjin

300060

Tianjin Medical University Cancer Institute and Hospital, Tianjin

310003

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

310009

Zhejiang University College of Medicine Second Affiliated Hospital, Hangzhou

310016

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

330006

The Second Affiliated Hospital of Nanchang University, Nanchang

350005

The First Affiliated Hospital of Fujian Medical University, Fuzhou

350014

Fujian Cancer Hospital, Fuzhou

400042

Daping Hospital, Third Military Medical University, Chongqing

400138

State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary, Volgograd

410008

Xiangya Hospital of Central South University, Changsha

410013

Hunan Cancer Hospital, Changsha

430022

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan

430079

Hubei Cancer Hospital, Wuhan

443011

Private Educational Institution of Higher Education Medical University Reaviz, Samara

450000

Henan Cancer Hospital, Zhengzhou

450003

Henan Provincial Peoples Hospital, Zhengzhou

450052

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

510060

Sun Yat Sen University Cancer Center, Guangzhou

510080

Guangdong Provincial Peoples Hospital, Guangzhou

518020

Shenzhen Peoples Hospital, Shenzhen

528000

Foshan First Peoples Hospital, Foshan

541001

Affiliated Hospital of Guilin Medical University, Guilin

570206

Hainan General Hospital, Haikou

630108

Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary, Novosibirsk

644013

Bih of Omsk Region Clinical Oncology Dispensary, Omsk

650100

Yunnan Cancer Hospital, Kunming

730000

The First Hospital of Lanzhou University, Lanzhou

050011

The Fourth Hospital of Hebei Medical University, Shijiazhuang

06100

Centre Antoine Lacassagne, Nice

260-8717

Chiba Cancer Center, Chiba

296-8602

Tesshokai Kameda General Hospital, Kamogawashi

791-0280

Nho Shikoku Cancer Center, Matsuyama

811-1395

Nho Kyushu Cancer Center, Fukuoka

373-8550

Gunma Prefectural Cancer Center, Otashi

060-8648

Hokkaido University Hospital, Sapporo

660-8511

Johas Kansai Rosai Hospital, Amagasakishi

920-8530

Ishikawa Prefectural Central Hospital, Kanazawa

761-0793

Kagawa University Hospital, Kitagun

241-8515

Kanagawa Cancer Center, Yokohama

879-5593

Oita University Hospital, Yufushi

710-8602

Kurashiki Central Hospital, Kurashikishi

700-8558

Okayama University Hospital, Okayama

594-0073

Izumi City General Hospital, Izumishi

540-0006

Nho Osaka National Hospital, Osakashi

565-0871

Osaka University Hospital, Suitashi

350-1298

Saitama Medical University International Medical Center, Hidakashi

362-0806

Saitama Cancer Center, Kitaadachigun

431-3192

Hamamatsu University School of Medicine, University Hospital, Hamamatsushi

104-0045

National Cancer Center Hospital, Chuoku

183-8524

Tokyo Metropolitan Tama Medical Center, Fuchushi

135-8550

Cancer Institute Hospital of Jfcr, Kotoku

162-8655

Center Hospital of the National Center For Global Health and Medicine, Shinjukuku

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

90-242

Centrum Terapii Wspolczesnej Jm Jasnorzewska Sp Komandytowo Akcyjna, Lodz

60-693

Przychodnia Med Polonia Sp Z Oo, Poznan

02-034

Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy, Warsaw

00935

Pan American Oncology Trials, Llc, Rio Piedras

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

01130

Acibadem Adana Hospital, Adana

06620

Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital, Ankara

07070

Akdeniz University Hospital, Konyaalt

CF14 2TL

Velindre Cancer Centre, Cardiff

W1G 6AD

Sarah Cannon Research Institute Uk, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BeiGene

INDUSTRY