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

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) Plus Platinum and Fluoropyrimidine Versus Placebo Plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Study Overview

• Status: Completed
• Conditions: Gastric, or Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: Tislelizumab; Drug: Cisplatin; Drug: Oxaliplatin; Drug: Capecitabine; Drug: 5-Fluorouracil; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 997
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • The First Affiliated Hospital of Bengbu Medical College
    • Hefei, Anhui, China, 230601
      • The second hospital of Anhui medical university
    • Hefei, Anhui, China, 230088
      • Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital
    • Beijing, Beijing, China, 100000
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100021
      • Cancer Hospital Chinese Academy of Medical Sciences
    • Beijing, Beijing, China, 100020
      • Beijing Chao Yang Hospital
    • Beijing, Beijing, China, 101149
      • Beijing Luhe Hospital, Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Daping Hospital, Third Military Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
    • Fuzhou, Fujian, China, 350005
      • The First Affiliated Hospital of Fujian Medical University
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • The First Hospital of Lanzhou University
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Foshan First Peoples Hospital
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial Peoples Hospital
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat Sen University Cancer Center
    • Shenzhen, Guangdong, China, 518020
      • Shenzhen Peoples Hospital
  • Guangxi
    • Guilin, Guangxi, China, 541001
      • Affiliated Hospital of Guilin Medical University
  • Hainan
    • Haikou, Hainan, China, 570206
      • Hainan General Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • The Fourth Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Harbin medical university cancer hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The first affiliated hospital of Zhengzhou university
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hospital
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial Peoples Hospital
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430022
      • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
    • Nantong, Jiangsu, China, 226000
      • Nantong Tumor Hospital Branch South
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The Second Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital and Institute
    • Shenyang, Liaoning, China, 110016
      • The General Hospital of Shenyang Military
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
    • Linyi, Shandong, China, 276001
      • Linyi Cancer Hospital
    • Qingdao, Shandong, China, 266000
      • The Affiliated Hospital of Qingdao University Branch South
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai General Hospital
    • Shanghai, Shanghai, China, 200092
      • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China, 200025
      • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China, 200032
      • Affiliated Zhongshan Hospital of Fudan University
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650100
      • Yunnan Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310003
      • The first Affiliated Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310009
      • Zhejiang University College of Medicine Second Affiliated Hospital
• France
  • Dijon, France, 21079
    • Centre Georges Francois Leclerc
  • Doubs, France, 25030
    • CHU Besançon Hopital Jean Minjoz
  • Marseille, France, 13005
    • Hopital de la Timone
  • Meurthe Et Moselle, France, 54519
    • ICL Alexis Vautrin
  • Montbeliard, France, 25200
    • Hopital Nord Franche Comte Site Du Mittan
  • Nice, France, 06100
    • Centre Antoine Lacassagne
  • Pessac, France, 33600
    • CHU Bordeaux Hopital Haut Leveque
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
  • Milano, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori Fondazione G Pascale
  • Padova, Italy, 35128
    • IOV Istituto Oncologico Veneto IRCCS
  • Pesaro, Italy, 61122
    • AO Ospedali Riuniti Marche Nord
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana
  • Roma, Italy, 133
    • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • San Giovanni Rotondo, Italy, 71013
    • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Siena, Italy, 53100
    • Aou Senese Policlinico Santa Maria Alle Scotte
  • Torino, Italy, 10126
    • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Torrette, Italy, 60020
    • Azienda Ospedaliera Universitaria Delle Marche
• Japan
  • Chiba
    • Chibashi, Chiba, Japan, 260-8717
      • Chiba Cancer Center
    • Kamogawashi, Chiba, Japan, 296-8602
      • Tesshokai Kameda General Hospital
  • Ehime
    • Matsuyamashi, Ehime, Japan, 791-0280
      • NHO Shikoku Cancer Center
  • Fukuoka
    • Fukuokashi, Fukuoka, Japan, 811-1395
      • Nho Kyushu Cancer Center
  • Gunma
    • Otashi, Gunma, Japan, 373-8550
      • Gunma Prefectural Cancer Center
  • Hokkaido
    • Sapporoshi, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Hyogo
    • Amagasakishi, Hyogo, Japan, 660-8511
      • JOHAS Kansai Rosai Hospital
  • Ishikawa
    • Kanazawashi, Ishikawa, Japan, 920-8530
      • Ishikawa Prefectural Central Hospital
  • Kagawa
    • Kitagun, Kagawa, Japan, 761-0793
      • Kagawa University Hospital
  • Kanagawa
    • Yokohamashi, Kanagawa, Japan, 241-8515
      • Kanagawa Cancer Center
  • Oita
    • Yufushi, Oita, Japan, 879-5593
      • Oita University Hospital
  • Okayama
    • Kurashikishi, Okayama, Japan, 710-8602
      • Kurashiki Central Hospital
    • Okayamashi, Okayama, Japan, 700-8558
      • Okayama University Hospital
  • Osaka
    • Izumishi, Osaka, Japan, 594-0073
      • Izumi City General Hospital
    • Osakashi, Osaka, Japan, 540-0006
      • NHO Osaka National Hospital
    • Suitashi, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Saitama
    • Hidakashi, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center
    • Kitaadachigun, Saitama, Japan, 362-0806
      • Saitama Cancer Center
  • Shizuoka
    • Hamamatsushi, Shizuoka, Japan, 431-3192
      • Hamamatsu University School of Medicine, University Hospital
  • Tokyo
    • Chuoku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Fuchushi, Tokyo, Japan, 183-8524
      • Tokyo Metropolitan Tama Medical Center
    • Kotoku, Tokyo, Japan, 135-8550
      • Cancer Institute Hospital of Jfcr
    • Shinjukuku, Tokyo, Japan, 162-8655
      • Center Hospital of the National Center for Global Health and Medicine
• Korea, Republic of
  • Gyeonggi-do
    • Goyangsi, Gyeonggi-do, Korea, Republic of, 10408
      • National Cancer Center
    • Seongnamsi, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
    • Suwonsi, Gyeonggi-do, Korea, Republic of, 16247
      • The Catholic University of Korea, St Vincents Hospital
    • Suwonsi, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
  • Gyeongsangbukdo
    • Daegu, Gyeongsangbukdo, Korea, Republic of, 41404
      • Kyungpook National University Chilgok Hospital
  • Jeollanam-do
    • HwasunGun, Jeollanam-do, Korea, Republic of, 58128
      • Chonnam National University Hwasun Hospital
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
      • Seoul National University Hospital
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
      • Severance Hospital Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
      • Asan Medical Center
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 6973
      • Chung Ang University Hospital
• Poland
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne
  • Lodz, Poland, 90-242
    • Centrum Terapii Wspolczesnej Jm Jasnorzewska Sp Komandytowo Akcyjna
  • Poznan, Poland, 60-693
    • Przychodnia Med Polonia Sp Z Oo
  • Warszawa, Poland, 02-034
    • Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Oncology Trials, LLC
• Russian Federation
  • Arkhangel'skaya Oblast'
    • Arkhangelsk, Arkhangel'skaya Oblast', Russian Federation, 163045
      • Arkhangelsk Regional Clinical Oncological Dispensary
  • Ivanovskaya Oblast'
    • Ivanovo, Ivanovskaya Oblast', Russian Federation, 153040
      • Rbih Ivanovo Regional Oncological Dispensary
  • Moskva
    • Moscow, Moskva, Russian Federation, 121309
      • VitaMed LLC
  • Novosibirskaya Oblast'
    • Novosibirsk, Novosibirskaya Oblast', Russian Federation, 630108
      • Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary
  • Omskaya Oblast'
    • Omsk, Omskaya Oblast', Russian Federation, 644013
      • Bih of Omsk Region Clinical Oncology Dispensary
  • Samaraskaya Oblast'
    • Samara, Samaraskaya Oblast', Russian Federation, 443011
      • Private Educational Institution of Higher Education Medical University Reaviz
  • Sankt-Peterburg
    • SaintPetersburg, Sankt-Peterburg, Russian Federation, 197022
      • Pavlov First Saint Petersburg State Medical University
    • SanktPetersburg, Sankt-Peterburg, Russian Federation, 197758
      • Fsbi Clinical Research and Practical Center For Specialized Medical Care (Oncology)
  • Volgogradskaya Oblast'
    • Volgograd, Volgogradskaya Oblast', Russian Federation, 400138
      • State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
  • Yaroslavskaya Oblast'
    • Yaroslavl, Yaroslavskaya Oblast', Russian Federation, 150054
      • Sbih of Yaroslavl Region Regional Clinical Oncological Hospital
• Spain
  • Barcelona, Spain, 8036
    • Hospital Clinic de Barcelona
  • Bilbao, Spain, 48013
    • Hospital de Basurto
  • Elche, Spain, 3203
    • Hospital General Universitario de Elche
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28050
    • Hospital Universitario Hm Madrid Sanchinarro
  • Majadahonda, Spain, 28222
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Malaga, Spain, 29010
    • Hospital Regional Universitario de Malaga
  • Pamplona, Spain, 31008
    • Complejo Hospitalario de Navarra
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain, 46010
    • Initia Oncologia, Slp
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung Ho Memorial Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• Turkey
  • Adana, Turkey, 01130
    • Acibadem Adana Hospital
  • Ankara, Turkey, 06620
    • Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
  • Battalgazi, Turkey, 44280
    • Nonu Universitesi Tip Fakultesi
  • Diyarbakir, Turkey, 21080
    • Dicle University Medical Faculty
  • Konyaalt, Turkey, 07070
    • Akdeniz University Hospital
  • Stanbul, Turkey, 34098
    • Iu C, Clinical Research Excellence Application and Research Center
  • Tekirdag, Turkey, 59100
    • Namik Kemal University
  • Trabzon, Turkey, 61080
    • Karadeniz Tecnical Uni Med Fac
• United Kingdom
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre Cancer Centre
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute UK
• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Health System
  • Georgia
    • Newnan, Georgia, United States, 30265
      • Southeastern Regional Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • West Reading, Pennsylvania, United States, 19611
      • Reading Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, Pllc Nashville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma
2. No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. NOTE: Participants may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months.
3. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 within 7 days prior to randomization
4. Adequate organ function ≤ 7 days prior to randomization

Key Exclusion Criteria:

1. Has squamous cell or undifferentiated or other histological type GC
2. Active leptomeningeal disease or uncontrolled brain metastasis
3. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
4. Prior therapy with an anti-programmed cell death protein-1 (PD-1), anti-programmed cell death protein ligand-1 (PD-L1), anti-programmed cell death protein ligand-2 (PD-L2), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tislelizumab + Chemotherapy; Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-fluorouracil (5-FU) on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.	Drug: Tislelizumab; 200 mg intravenously (IV) on Day 1 of each 21-day cycle; Other Names: BGB-A317; TEVIMBRA®; 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
Placebo Comparator: Placebo + Chemotherapy; Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-FU on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.	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; Drug: Placebo; Placebo to match tislelizumab IV on Day 1 of each 21-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival in PD-L1 Positive Participants	Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.	From randomization up to the primary analysis data cut-off date of 8 October 2021; Median (range) time on follow-up was 11.8 (0.1 - 33.4) months.
Overall Survival in the Intent-to-Treat (ITT) Analysis Set	Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.	From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) in PD-L1 Positive Participants	Progression-free survival is defined as the time from the date of randomization to the date of the first objectively documented tumor progression assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.	From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.
Overall Response Rate (ORR) in PD-L1 Positive Participants	ORR is defined as the percentage of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1 assessed by the investigator. Investigators conducted assessments of radiological tumor response by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits.	Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.
Progression-free Survival (PFS) in the ITT Analysis Set	Progression-free survival is defined as the time from the date of randomization to the date of the first objectively documented tumor progression assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.	From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.
Overall Response Rate (ORR) in the ITT Analysis Set	ORR is defined as the percentage of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1 assessed by the investigator. Investigators conducted assessments of radiological tumor response by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits.	Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.
Duration of Response (DOR) in PD-L1 Positive Participants	DOR is defined as the time from the first determination of an objective response assessed by the investigator per RECIST v1.1, until the first documentation of progression or death, whichever occurred first. Progressive disease (PD): At least a 20% increase in the size of target lesions, taking as reference the smallest size on study, with an absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or any new lesions.	Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.
Duration of Response in the ITT Analysis Set	DOR is defined as the time from the first determination of an objective response assessed by the investigator per RECIST v1.1, until the first documentation of progression or death, whichever occurred first. Progressive disease (PD): At least a 20% increase in the size of target lesions, taking as reference the smallest size on study, with an absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or any new lesions.	Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores	The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life.	Baseline and Cycles 4 and 6
Change From Baseline in EORTC QLQ-C30 Fatigue Score	The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. The fatigue symptom scale includes 3 items and ranges from 0 to 100, where higher scores indicate a higher level of symptoms.	Baseline and Cycles 4 and 6
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22)	EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales: Dysphagia/odynophagia (4 items), Pain/discomfort (3 items), Dietary restrictions (5 items), Upper gastro-intestinal (GI) symptoms (3 items), Specific emotional problems (3 items) and 4 single items. Each question is answered on a scale from 0 (Not at all) to 4 (Very Much), where lower scores indicate fewer symptoms/better QoL. Raw scores were transformed to a scale from 0 to 100, where lower scores indicate better QoL. The QLQ-STO22 Index score is the mean of the 6 domain scores and 4 single items.	Baseline and Cycles 4 and 6
Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)	The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.	Baseline and Cycles 4 and 6
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not. An SAE is any untoward medical occurrence that, at any dose met any of the following criteria: Resulted in death; Was life-threatening; Required hospitalization or prolongation of existing hospitalization; Resulted in disability/incapacity; Was a congenital anomaly/birth defect; Was considered a significant medical AE by the Investigator based on medical judgement.	From first dose of study drug to 30 days after last dose or the initiation of a new anticancer therapy, whichever occurred first, up to the end of study; maximum treatment duration was 59.3 months in Tislelizumab and 56.8 months in the Placebo group.
Disease Control Rate in PD-L1 Positive Participants	Disease Control Rate is defined as the percentage of participants who had confirmed CR, PR, or stable disease (SD) assessed by the investigator and the investigator per RECIST v1.1. Investigators conducted assessments of radiological tumor response by CT or MRI per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: Neither sufficient shrinkage in size of lesions to qualify for PR nor sufficient increase to qualify for PD, and no new lesions.	Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.
Disease Control Rate in the ITT Analysis Set	Disease Control Rate is defined as the percentage of participants who had confirmed CR, PR, or stable disease (SD) assessed by the investigator per RECIST v1.1. Investigators conducted assessments of radiological tumor response by CT or MRI per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: Neither sufficient shrinkage in size of lesions to qualify for PR nor sufficient increase to qualify for PD, and no new lesions.	Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.
Clinical Benefit Rate (CBR) in PD-L1 Positive Participants	Clinical benefit rate is defined as the percentage of participants who achieved a confirmed complete response, partial response, or durable stable disease assessed by the Investigator per RECIST v1.1. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. Durable SD: Stable disease for ≥ 24 weeks.	Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.
Clinical Benefit Rate (CBR) in the ITT Analysis Set	Clinical benefit rate is defined as the percentage of participants who achieved a confirmed complete response, partial response, or durable stable disease assessed by the Investigator per RECIST v1.1. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. Durable SD: Stable disease for ≥ 24 weeks.	Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.
Time to Response (TTR) in PD-L1 Positive Participants	Time to response is defined as the time from randomization to the first determination of an objective response per RECIST version 1.1 as assessed by the investigator.	From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.
Time to Response (TTR) in the ITT Analysis Set	Time to response is defined as the time from randomization to the first determination of an objective response per RECIST version 1.1 as assessed by the investigator.	From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Jin Wang, MD, BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): August 27, 2024

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Esophageal Diseases; Carcinoma; Esophageal Neoplasms; Adenocarcinoma; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Capecitabine; Oxaliplatin; Tislelizumab; Fluorouracil
• Other Study ID Numbers: BGB-A317-305; 2018-000312-24 (EudraCT Number); CTR20181841 (Registry Identifier: ChinaDrugTrials); JapicCTI-194799 (Registry Identifier: Japic)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No