Gastric, or Gastroesophageal Junction Adenocarcinoma Clinical Trial
Official title:
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
| Verified date | February 2024 |
| Source | BeiGene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
| Status | Active, not recruiting |
| Enrollment | 997 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | February 28, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Key Inclusion Criteria: 1. Locally advanced unresectable or metastatic GC or 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. ECOG PS = 1 within 7 days prior to randomization 4. Adequate organ function as indicated by the following laboratory values = 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-PD-1, anti-PD-L1, anti-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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Cancer Hospital | Beijing | Beijing |
| China | Beijing Chao Yang Hospital | Beijing | Beijing |
| China | Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing |
| China | Beijing Luhe Hospital | Beijing | Beijing |
| China | Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing |
| China | Chinese PLA General Hospital Medical School of Chinese PLA | Beijing | Beijing |
| China | No. 3 Hospital, Beijing University | Beijing | Beijing |
| China | Peking Union Medical College Hospital | Beijing | Beijing |
| China | The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui |
| China | The First Hospital of Jilin University | Changchun | Jilin |
| China | Hunan Cancer Hospital | Changsha | Hunan |
| China | Xiangya Hospital Central South University | Changsha | Hunan |
| China | Daping Hospital of The 3rd Military University | Chongqing | Sichuan |
| China | The First People's Hospital of Foshan | Foshan | Guangdong |
| China | Fujian Cancer Hospital | Fuzhou | Fujian |
| China | The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian |
| China | Guangdong General Hospital | Guangzhou | Guangdong |
| China | Sun Yat-sen University, Cancer Center | Guangzhou | Guangdong |
| China | The First Affiliated Hospital of Guilin Medical University | Guilin | Guangxi |
| China | Hainan General Hospital | Haikou | Hainan |
| China | Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine | Hangzhou | Zhejiang |
| China | The First Affiliated Hospital, Zhejiang University | Hangzhou | Zhejiang |
| China | The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang |
| China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
| China | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang |
| China | Anhui Provincial Cancer Hospital | Hefei | Anhui |
| China | The Second Hospital of Anhui Medical University | Hefei | Anhui |
| China | Shandong Cancer Hospital | Jinan | Shandong |
| China | Yunnan Cancer Hospital | Kunming | Yunnan |
| China | The First Hospital of Lanzhou University | Lanzhou | Gansu |
| China | Linyi Cancer Hospital | Linyi | Shandong |
| China | The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi |
| China | Jiangsu Cancer Hospital | Nanjing | Jiangsu |
| China | Jiangsu Province Hospital | Nanjing | Jiangsu |
| China | The Affiliated Drum Tower Hospital of Nanjing University | Nanjing | Jiangsu |
| China | Nantong Tumor Hospital | Nantong | Jiangsu |
| China | The Affiliated Hospital of Qingdao University | Qingdao | Shandong |
| China | Ruijin Hospital, Shanghai Jiaotong Uni. School of Med. | Shanghai | Shanghai |
| China | Shanghai General Hospital | Shanghai | Shanghai |
| China | Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
| China | Zhongshan Hospital Fudan University | Shanghai | Shanghai |
| China | General Hospital of Shenyang Military Region | Shenyang | Liaoning |
| China | Liaoning Cancer Hospital & Institute | Shenyang | Liaoning |
| China | The First Hospital of China Medical University | Shenyang | Liaoning |
| China | Shenzhen People's Hospital | Shenzhen | Guangdong |
| China | Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei |
| China | Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin |
| China | Tianjin Medical University General Hospital | Tianjin | Tianjin |
| China | Hubei Cancer Hospital | Wuhan | Hubei |
| China | Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
| China | Henan Cancer Hospital | Zhengzhou | Henan |
| China | Henan Provincial People's Hospital | Zhengzhou | Henan |
| China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
| France | CHU Besançon - Hôpital Jean Minjoz | Besançon | |
| France | Centre Georges François Leclerc | Dijon cedex | Côte-d'Or |
| France | Hôpital de la Timone | Marseille | |
| France | Hôpital Nord Franche Comté | Montbéliard | |
| France | Centre Antoine Lacassagne | Nice cedex 02 | Alpes Maritimes |
| France | CHU Bordeaux - Hôpital Haut-Lévêque | Pessac | Gironde |
| Italy | Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi | Bologna | |
| Italy | Istituto Nazionale Tumori Fondazione G. Pascale | Napoli | |
| Italy | IOV - Istituto Oncologico Veneto IRCCS | Padova | |
| Italy | Azienda Ospedaliero Universitaria Pisana | Pisa | |
| Italy | Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Roma | |
| Italy | IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Foggia |
| Italy | Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | |
| Italy | Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona | Torrette | Ancona |
| Japan | JOHAS Kansai Rosai Hospital | Amagasaki-shi | Hyogo-ken |
| Japan | Chiba Cancer Center | Chiba-shi | Chiba-Ken |
| Japan | National Cancer Center Hospital | Chuo-ku | Tokyo-To |
| Japan | Tokyo Metropolitan Tama Medical Center | Fuchu-shi | Tokyo-to |
| Japan | Fukui Prefectural Hospital | Fukui-shi | Fukui-ken |
| Japan | NHO Kyushu Cancer Center | Fukuoka-shi | Fukuoka-Ken |
| Japan | Hamamatsu University School of Medicine, University Hospital | Hamamatsu-shi | Shizuoka-Ken |
| Japan | Saitama Medical University International Medical Center | Hidaka-shi, | Saitama-ken |
| Japan | Hiroshima City Hiroshima Citizens Hospita | Hiroshima-shi | Hiroshima-ken, |
| Japan | Saitama Cancer Center | Ina | Saitama |
| Japan | Izumi City General Hospital | Izumi-shi | Osaka-Fu |
| Japan | Tesshokai Kameda General Hospital | Kamogawa-shi | Chiba-ken |
| Japan | Ishikawa Prefectural Central Hospital | Kanazawa-shi | Ishikawa-ken |
| Japan | Kagawa University Hospital | Kita-gun | Kagawa-Ken |
| Japan | Cancer Institute Hospital of JFCR | Koto-ku | Tokyo-To |
| Japan | Kurashiki Central Hospital | Kurashiki | |
| Japan | Kurashiki Central Hospital | Kurashiki-shi | Okayama-ken |
| Japan | Okayama University Hospital | Okayama-shi | Okayama-ken |
| Japan | Osaki Citizen Hospital | Osaka | |
| Japan | Osaka Medical and Pharmaceutical University Hospital | Osaka-fu | Takatsuki-shi |
| Japan | NHO Osaka National Hospital | Osaka-shi | Osaka-fu |
| Japan | Gunma Prefectural Cancer Center | Ota-shi | Gunma -ken |
| Japan | Hokkaido University Hospital | Sapporo-shi | Hokkaido |
| Japan | Center Hospital of the National Center for Global Health and Medicine | Shinjuku-ku | Tokyo-To |
| Japan | Osaka International Cancer Institute - Clinical Oncology | Suita | Osaka |
| Japan | Osaka University Hospital | Suita | Osaka |
| Japan | NHO Takasaki General Medical Center | Takasaki-shi | Gunma-ken |
| Japan | Kanagawa Cancer Center | Yokohama | Kanagawa |
| Japan | Oita University Hospital | Yufu-shi | Oita-Ken |
| Korea, Republic of | Kyungpook National University Chilgok Hospital | Daegu | Gyeongsangbuk-do |
| Korea, Republic of | National Cancer Center | Goyang-si | Gyeonggi-do |
| Korea, Republic of | Chonnam National University Hwasun Hospital | Hwasun | Jeollanam-do |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Chung-Ang University Hospital | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University | Seoul | Gyeonggi-do |
| Korea, Republic of | Ajou University Hospital | Suwon | Gyeonggi-do |
| Korea, Republic of | The Catholic University of Korea, St. Vincent's Hospital | Suwon-si | Gyeonggi-do |
| Poland | Uniwersyteckie Centrum Kliniczne | Gdansk | |
| Poland | Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna | Lodz | |
| Poland | Przychodnia Med-Polonia Sp. z o.o. | Poznan | |
| Poland | Centrum Onkologii-Instytut im. M. Sklodowskiej Curie | Warszawa | |
| Puerto Rico | Pan American Oncology Trials, LLC | San Juan | |
| Russian Federation | RBIH "Ivanovo Regional Oncological Dispensary" | Ivanovo | |
| Russian Federation | "VitaMed" LLC | Moscow | |
| Russian Federation | SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" | Moscow | |
| Russian Federation | SBHI of Novosibirsk | Novosibirsk | |
| Russian Federation | BHI of Omsk region "Clinical Oncology Dispensary" | Omsk | |
| Russian Federation | FSBI "Clinical Research and Practical Center for specialized medical care (oncology)" | Pesochnyy | |
| Russian Federation | Pavlov First Saint Petersburg State Medical University | Saint Petersburg | |
| Russian Federation | Private Educational Institution of Higher Education "Medical University "REAVIZ" | Samara | |
| Russian Federation | SBIH " Volgograd Regional Clinical Oncological Dispensary # 1" | Volgograd | |
| Russian Federation | SBIH of Yaroslavl region "Regional Clinical Oncological Hospital" | Yaroslavl | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital de Basurto | Bilbao | |
| Spain | Hospital General Universitario de Elche | Elche | |
| Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
| Spain | Hospital Universitario HM Madrid Sanchinarro | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | |
| Spain | Hospital Regional Universitario de Malaga | Málaga | |
| Spain | Complejo Hospitalario de Navarra | Pamplona | |
| Spain | Hospital Universitario Virgen del Rocio | Sevilla | |
| Spain | Hospital Clinico Universitario de Valencia | Valence | |
| Spain | Initia Oncologia, SLP | Valencia | |
| Spain | Hospital Universitario Miguel Servet | Zaragoza | |
| Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | |
| Taiwan | National Cheng Kung University Hospital | Tainan | |
| Taiwan | Taipei Veterans General Hospital | Taipei | |
| Turkey | Acibadem Adana Hospital | Adana | |
| Turkey | Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital | Ankara | |
| Turkey | Akdeniz University Medical Faculty | Antalya | |
| Turkey | Inonu Uni. Med. Fac. | Malatya | |
| United Kingdom | Velindre Cancer Centre | Cardiff | |
| United Kingdom | Sarah Cannon Research Institute UK | London | |
| United States | Ohio State University Hospital | Columbus | Ohio |
| United States | Tennessee Oncology, PLLC - Nashville | Nashville | Tennessee |
| United States | Southeastern Regional Medical Center | Newnan | Georgia |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University Hospital - Central | Philadelphia | Pennsylvania |
| United States | University of California Davis Health System | Sacramento | California |
| United States | Reading Hospital | West Reading | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| BeiGene |
United States, China, France, Italy, Japan, Korea, Republic of, Poland, Puerto Rico, Russian Federation, Spain, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) | The time from the date of randomization to the date of death due to any cause | Up to 48 months | |
| Secondary | Progression-free survival (PFS) | The time from the date of randomization to the date of the first objectively documented tumor progression | Up to 30 months | |
| Secondary | Overall response rate (ORR) | The proportion of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1 | Up to 48 months | |
| Secondary | Duration of response (DOR) | The time from the first determination of an objective response per Response Evaluation Criteria in Solid Tumors v1.1, until the first documentation of progression or death, whichever occurs first | Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months | |
| Secondary | Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22) | Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months | ||
| Secondary | Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (EORTC QLQ-30) | Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months | ||
| Secondary | Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score (EQ-5D-5L) | Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months | ||
| Secondary | Number of participants experiencing Adverse Events (AEs) | Up to 48 months | ||
| Secondary | Number of participants experiencing Serious Adverse Events (SAEs) | Up to 48 months | ||
| Secondary | Disease control rate (DCR) | Proportion of complete response + partial response + stable disease | Up to 48 Months | |
| Secondary | clinical benefit rate (CBR) | Proportion of complete response + partial response + durable stable disease | Up to 48 Months | |
| Secondary | time to response (TTR) | Time from randomization to the first determination of an objective response | Up to 48 Months |