A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
- Interventions
- Registration Number
- NCT03430843
- Lead Sponsor
- BeiGene
- Brief Summary
The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 512
- Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
- Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC
- At least one measurable/evaluable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization
Key
- Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable ESCC
- History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization
- Tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
- Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
- Prior malignancy active within the previous 2 years (exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast)
- Active brain or leptomeningeal metastasis.
- Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
- Known history of, or any evidence of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases, etc
- Known history of Human Immunodeficiency Virus (HIV)
- Has cardiovascular risk factors
- Pregnant or breastfeeding woman.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tislelizumab Tislelizumab Tislelizumab on Day 1, given every 21 days Investigator chosen chemotherapy (ICC) Paclitaxel Paclitaxel on Day 1, given every 21 days or on a weekly schedule; OR Docetaxel on Day 1, given every 21 days; OR Irinotecan on Days 1 and 8, given every 21 days Investigator chosen chemotherapy (ICC) Docetaxel Paclitaxel on Day 1, given every 21 days or on a weekly schedule; OR Docetaxel on Day 1, given every 21 days; OR Irinotecan on Days 1 and 8, given every 21 days Investigator chosen chemotherapy (ICC) Irinotecan Paclitaxel on Day 1, given every 21 days or on a weekly schedule; OR Docetaxel on Day 1, given every 21 days; OR Irinotecan on Days 1 and 8, given every 21 days
- Primary Outcome Measures
Name Time Method Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set Approximately 2 years and 10 months from date of first randomization OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) in the PDL-1 Positive Analysis Set Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%.
Objective Response Rate (ORR) in the ITT Analysis Set Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1;
Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) 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; reported for the PDL-1 Positive Analysis Set
Duration of Response (DOR) in the ITT Analysis Set Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set Baseline to Cycle 6 (21 days per cycle) Mean change from baseline in EORTC QLQ-C30 Index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes
Number of Participants Experiencing Adverse Events (AEs) From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs
Progression-free Survival (PFS) in the ITT Analysis Set Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) 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; reported for the ITT analysis set
Duration of Response (DOR) in the PDL-1 Positive Analysis Set. Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set Baseline to Cycle 6 (21 days per cycle) Mean change from baseline in EORTC QLQ-C30 index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes
HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set Baseline to Cycle 6 (21 days per cycle) Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set. Baseline to Cycle 6 (21 days per cycle) Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set Baseline to Cycle 6 (21 days per cycle) Mean change from baseline in EQ-5D-5L visual acuity score (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.
HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set Baseline to Cycle 6 (21 days per cycle) Mean change from baseline in EQ-5D-5L visual acuity score (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.
Trial Locations
- Locations (137)
UZ Antwerpen
🇧🇪Antwerp, Belgium
Anhui Medical University - The Second Hospital
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
The Sixth Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Hangzhou First People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital)
🇨🇳Xi'an, Shanxi, China
Sichuan Academy of Medical Sciences& Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Yunnan Cancer Hospital - Oncology
🇨🇳Kunming, Yunnan, China
University Hospitals Leuven
🇧🇪Leuven, Belgium
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
St. Joseph Heritage Healthcare
🇺🇸Fullerton, California, United States
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Imelda Ziekenhuis
🇧🇪Antwerp, Belgium
Fujian Provincial Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Cancer Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
AUSL della Romagna, Osp. degli Infermi
🇮🇹Faenza, Italy
AOU San Luigi di Orbassano
🇮🇹Orbassano, Italy
Comprehensive Cancer Center-Gustave Roussy
🇫🇷Paris, France
Shikoku Cancer Center
🇯🇵Matsuyama, Ehime, Japan
CHRU de Brest Hôpital Morvan
🇫🇷Brest, France
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
ICM Val d'Aurelle
🇫🇷Montpellier, France
Universitatsklinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik
🇩🇪Dresden, Germany
Shandong Linyi Tumor Hospital
🇨🇳Linyi, Shandong, China
WeiFang People's Hospital
🇨🇳Weifang, Shandong, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
AOU - Seconda Università degli Studi di Napoli
🇮🇹Naples, Italy
Centre de Lutte Contre le Cancer
🇫🇷Saint-Herblain, France
CHRU Besançon
🇫🇷Besançon, France
Fudan Cancer Hospital
🇨🇳Shanghai, Shanghai, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, Hebei, China
Centre Georges-Francois Leclerc
🇫🇷Dijon, France
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The First People's Hospital Of Changzhou
🇨🇳Changzhou, Jiangsu, China
University of Southern California Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Hopital Prive Jean Mermoz
🇫🇷Lyon, France
Hôpital Haut-Lévêque
🇫🇷Pessac, France
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
The Cancer Institute Hospital of JFCR
🇯🇵Koto-Ku, Tokyo, Japan
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hyogo Cancer Center
🇯🇵Akashi, Hyogo, Japan
Kliniken Nordoberpfalz, Klinikum Weiden
🇩🇪Weiden, Germany
Saitama Cancer Center
🇯🇵Ina, Saitama, Japan
Hospital Madrid Norte Sanchinarro
🇪🇸Madrid, Spain
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Changhua Christian Hospital
🇨🇳Changhua, NAP, Taiwan
Chi Mei Medical Center
🇨🇳Tainan, Taiwan
Chi Mei Hospital, Liouying
🇨🇳Tainan, Taiwan
Institut Català d'Oncologia
🇪🇸Madrid, Spain
Hospital Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Kindai University Nara Hospital
🇯🇵Ikoma, Nara, Japan
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Northwestern Medicine Cancer Center Warrenville
🇺🇸Warrenville, Illinois, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Millennium Oncology
🇺🇸Houston, Texas, United States
PO Garibaldi-Nesima, ARNAS Garibaldi
🇮🇹Catania, Italy
Irccs Irst
🇮🇹Meldola, Italy
A.O.U. Pisana, Stabilimento di Santa Chiara
🇮🇹Pisa, Italy
Clinique Sainte-Anne
🇫🇷Strasbourg, France
St. Marianna University School of Medicine Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Akita University Hospital
🇯🇵Akita, Japan
Kagawa University Hospital
🇯🇵Kagawa, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
Guys & St. Thomas Hospital
🇬🇧London, United Kingdom
The Royal Marsden NHS Foundation Trust - Haemato-Oncology
🇬🇧Sutton, United Kingdom
Mount Vernon Cancer Centre
🇬🇧Northwood, United Kingdom
St. George's Hospital
🇬🇧London, United Kingdom
The Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom
Universitaetsmedizin der Johannes Gutenberg-Universitat Mainz
🇩🇪Mainz, Germany
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
San Antonio Military Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Cliniques universitaires Saint-Luc
🇧🇪Brussels, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Site du Sart Tilman
🇧🇪Liege, Belgium
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The First Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Xiangyang Central Hospital
🇨🇳Xiangyang, Hubei, China
Nantong Tumor Hospital
🇨🇳Nantong, Jiangsu, China
Huai'an Second People's Hospital
🇨🇳Huai'an, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The First Hospital of Jinlin University
🇨🇳Changchun, Jilin, China
Shanxi Provincial People's Hospital
🇨🇳Taiyuan, Shanxi, China
Center Oscar Lambret - Alliance Member
🇫🇷Lille, France
Hamatologisch-Onkologische Praxis Eppendorf (HOPE)
🇩🇪Hamburg, Germany
Universitaetsmedizin Mannheim, II. Medizinische Klinik
🇩🇪Mannheim, Germany
Universitatsklinikum Koln, Innere Medizin I
🇩🇪Koln, Germany
Asklepios Klinik Altona
🇩🇪Hamburg, Germany
Universitat Leipzig, UKL AoR, Universitares Krebszentrum Leipzig (UCCL)
🇩🇪Leipzig, Germany
Ospedale Guglielmo da Saliceto, AUSL Piacenza
🇮🇹Piacenza, Italy
AO Citta della Salute e della Scienza di Torino - Presidio O
🇮🇹Torino, Italy
Shizuoka Cancer Center
🇯🇵Nagaizumi, Shizuoka, Japan
National Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Kochi Health Sciences Center
🇯🇵Kochi, Japan
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
China Medical University Hospital
🇨🇳Taichung, Taiwan
Sarah Cannon Research Institute-London
🇬🇧London, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Chiba Cancer Center
🇯🇵Chiba, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Osaka Medical College Hospital
🇯🇵Osaka, Japan
CHU de Poitiers
🇫🇷Poitiers, France
Charite - Universitatsmedizin Berlin /Campus Virchow Klinikum (CVK) - Med. Klinik m. S. Hamatologie, Onkologie und Tumorimmunologie (CC14)
🇩🇪Berlin, Germany
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Chonnam National University Hwasun Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Asan Medical Center - Oncology
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Hospital del Mar
🇪🇸Barcelona, Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Imperial NHS Trust
🇬🇧London, United Kingdom
Hospital Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Toledo Clinic Cancer Center
🇺🇸Toledo, Ohio, United States
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Imelda Ziekenhuis Bonheiden
🇧🇪Bonheiden, Belgium
Cliniques Universitaires Saint Luc
🇧🇪Brussels, Belgium
Uz Antwerpen
🇧🇪Edegem, Belgium
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China