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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003983-10 | EudraCT Number | ||
| CTR20171257 | Registry Identifier | Center for drug evaluation, CFDA |
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This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1 monoclonal antibody BGB-A317 in participants with previously treated hepatocellular unresectable carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab | Experimental | 200 milligrams once every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Administered intravenously |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC) | ORR is defined as the percentage of participants with complete response (CR) and partial response (PR) as the best overall response, as determined by an IRC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions. | From date of first dose to primary analysis data cut-off date of 30-June-2021 (up to approximately 3 years and 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR Assessed by Investigator | ORR is defined as the percentage of participants with CR and PR as the best overall response, as determined by investigator assessment using RECIST v1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions. | From date of first dose to end of study (up to approximately 4 years and 3 months) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
Prior therapies targeting PD-1 or PD-L1
Has known brain or leptomeningeal metastasis
Tumor thrombus involving main trunk of portal vein or inferior vena cava
Loco-regional therapy to the liver within 4 weeks before enrollment
Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, or acute lung diseases
Has received:
Active autoimmune diseases or history of autoimmune diseases that may relapse
Participant with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230000 | China | ||
| The Second Hospital of Anhui Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36872927 | Background | Ren Z, Ducreux M, Abou-Alfa GK, Merle P, Fang W, Edeline J, Li Z, Wu L, Assenat E, Hu S, Rimassa L, Zhang T, Blanc JF, Pan H, Ross P, Yen CJ, Tran A, Shao G, Bouattour M, Chen Y, Meyer T, Hou J, Tougeron D, Bai Y, Hou MM, Meng Z, Wu J, Li V, Chica-Duque S, Cheng AL. Tislelizumab in Patients with Previously Treated Advanced Hepatocellular Carcinoma (RATIONALE-208): A Multicenter, Non-Randomized, Open-Label, Phase 2 Trial. Liver Cancer. 2022 Oct 4;12(1):72-84. doi: 10.1159/000527175. eCollection 2023 Feb. | |
| 34518988 |
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This study was conducted at 73 study centers in Mainland China, Taiwan, Italy, Germany, France, Spain, Poland, and the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tislelizumab | Tislelizumab 200 milligrams (mg) administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2018 | Jul 3, 2023 |
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| Duration of Response (DOR) Assessed by IRC | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using RECIST v1.1 | From date of first dose to end of study (up to approximately 4 years and 3 months) |
| DOR Event-Free Rate Assessed by IRC | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using RECIST v1.1. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 12 and 24 months with 95% confidence intervals estimated using Greenwood's formula. | From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported |
| DOR Assessed by Investigator | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using RECIST v1.1 | From date of first dose to end of study (up to approximately 4 years and 3 months) |
| DOR Event-Free Rate Assessed by Investigator | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using RECIST v1.1. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 12 and 24 months with 95% confidence intervals estimated using Greenwood's formula. | From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported |
| Progression-free Survival (PFS) Assessed by IRC | PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the IRC using RECIST v1.1 | From date of first dose to end of study (up to approximately 4 years and 3 months) |
| PFS Assessed by Investigator | PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.1 | From date of first dose to end of study (up to approximately 4 years and 3 months) |
| Overall Survival (OS) | OS is defined as the time from first study drug administration to the date of death due to any cause | From date of first dose to end of study (up to approximately 4 years and 3 months) |
| Disease Control Rate (DCR) Assessed by IRC | DCR is defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by the IRC using RECIST v1.1 | From date of first dose to end of study (up to approximately 4 years and 3 months) |
| DCR Assessed by Investigator | DCR is defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by the investigator using RECIST v1.1 | From date of first dose to end of study (up to approximately 4 years and 3 months) |
| Clinical Benefit Rate (CBR) Assessed by IRC | CBR is defined as the percentage of participants who have CR, PR, or SD of ≥ 24 weeks in duration as assessed by the IRC using RECIST v1.1 | From date of first dose to end of study (up to approximately 4 years and 3 months) |
| CBR Assessed by Investigator | CBR is defined as the percentage of participants who have CR, PR, or SD of ≥ 24 weeks in duration as assessed by the investigator using RECIST v1.1 | From date of first dose to end of study (up to approximately 4 years and 3 months) |
| European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analogue Score (VAS) | Mean change from baseline in EQ-5D-5L 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 to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days) |
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status | Mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients. 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. | Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days) |
| EORTC QLQ - Hepatocellular Carcinoma 18 Questions (HCC18): Index Scores | Mean change from baseline in EORTC QLQ HCC18 Index Scores. The EORTC QLQ HCC18 is a specific questionnaire module that assesses quality of life of cancer patients 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. | Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days) |
| Number of Participants With Adverse Events | 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 | From first dose up to 30 days after the last dose of study drug; up to approximately 4 years and 3 months |
| Hefei |
| Anhui |
| 230601 |
| China |
| Military Hospital of China | Beijing | Beijing Municipality | 100039 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Chinese Pla General Hospital | Beijing | Beijing Municipality | 100853 | China |
| Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) | Guangzhou | Guangdong | 510245 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Xuzhou Central Hospital | Xuzhou | Jiangsu | 221000 | China |
| The First Affiliated Hospital of Nanchang University Branch Donghu | Nanchang | Jiangxi | 330006 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130021 | China |
| Weifang Peoples Hospital | Weifang | Shandong | 261000 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Zhejiang University College of Medicine Second Affiliated Hospital | Hangzhou | Zhejiang | 310009 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| Hopital Beaujon | Clichy | 92210 | France |
| Hopital de La Croix Rousse | Lyon | 69317 | France |
| Chu Montpellier Hopital Saint Eloi | Montpellier | 34295 | France |
| Centre Hospitalier Universitaire Nantes Hotel Dieu | Nantes | 44093 | France |
| Hopital Larchet Chu Nice | Nice | 6200 | France |
| Groupe Hospitalier Du Haut Leveque | Pessac | 33604 | France |
| Chu de Poitiers Site de La Mileterie | Poitiers | 86000 | France |
| Centre Eugene Marquis | Rennes | 35043 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Kliniken Essen Mitte Evang Huyssens Stiftung | Essen | 45136 | Germany |
| Universitatsklinikum Hamburg Eppendorf | Hamburg | 20251 | Germany |
| Klinikum Johannes Gutenberg Universitaet Mainz | Mainz | 55131 | Germany |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56126 | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy | Warsaw | 02-034 | Poland |
| Hospital Universitario Vall Dhebron | Barcelona | 08035 | Spain |
| Ico Lhospitalet Hospital Duran I Reynals | Barcelona | 08908 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Hm Madrid Sanchinarro | Madrid | 28050 | Spain |
| E Da Hospital Kaohsiung | Kaohsiung City | 82445 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | 33305 | Taiwan |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| The Christie Hospital | Greater Manchester | M20 4BX | United Kingdom |
| Royal Free Hospital London Nhs Trust | London | NW3 2QG | United Kingdom |
| Kings College | London | SE5 9RS | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Background |
| Serrano D, Podger L, Barnes G, Song J, Tang B. Psychometric validation of the EORTC QLQ-HCC18 in patients with previously treated unresectable hepatocellular carcinoma. Qual Life Res. 2022 Mar;31(3):937-950. doi: 10.1007/s11136-021-02992-1. Epub 2021 Sep 13. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tislelizumab | Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status Score | ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC) | ORR is defined as the percentage of participants with complete response (CR) and partial response (PR) as the best overall response, as determined by an IRC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions. | Safety analysis set included all participants who received ≥ 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of first dose to primary analysis data cut-off date of 30-June-2021 (up to approximately 3 years and 3 months) |
|
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| Secondary | ORR Assessed by Investigator | ORR is defined as the percentage of participants with CR and PR as the best overall response, as determined by investigator assessment using RECIST v1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions. | Safety analysis set included all participants who received ≥ 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of first dose to end of study (up to approximately 4 years and 3 months) |
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| Secondary | Duration of Response (DOR) Assessed by IRC | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using RECIST v1.1 | Safety analysis set included all participants who received ≥ 1 dose of study drug | Posted | Median | 95% Confidence Interval | Months | From date of first dose to end of study (up to approximately 4 years and 3 months) |
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| Secondary | DOR Event-Free Rate Assessed by IRC | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using RECIST v1.1. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 12 and 24 months with 95% confidence intervals estimated using Greenwood's formula. | Safety analysis set included all participants who received ≥ 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported |
|
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| Secondary | DOR Assessed by Investigator | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using RECIST v1.1 | Safety analysis set included all participants who received ≥ 1 dose of study drug | Posted | Median | 95% Confidence Interval | Months | From date of first dose to end of study (up to approximately 4 years and 3 months) |
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| Secondary | DOR Event-Free Rate Assessed by Investigator | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using RECIST v1.1. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 12 and 24 months with 95% confidence intervals estimated using Greenwood's formula. | Safety analysis set included all participants who received ≥ 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported |
|
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| Secondary | Progression-free Survival (PFS) Assessed by IRC | PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the IRC using RECIST v1.1 | Safety analysis set included all participants who received ≥ 1 dose of study drug | Posted | Median | 95% Confidence Interval | Months | From date of first dose to end of study (up to approximately 4 years and 3 months) |
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| Secondary | PFS Assessed by Investigator | PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.1 | Safety analysis set included all participants who received ≥ 1 dose of study drug | Posted | Median | 95% Confidence Interval | Months | From date of first dose to end of study (up to approximately 4 years and 3 months) |
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| Secondary | Overall Survival (OS) | OS is defined as the time from first study drug administration to the date of death due to any cause | Safety analysis set included all participants who received ≥ 1 dose of study drug | Posted | Median | 95% Confidence Interval | Months | From date of first dose to end of study (up to approximately 4 years and 3 months) |
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| Secondary | Disease Control Rate (DCR) Assessed by IRC | DCR is defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by the IRC using RECIST v1.1 | Safety analysis set included all participants who received ≥ 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of first dose to end of study (up to approximately 4 years and 3 months) |
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| Secondary | DCR Assessed by Investigator | DCR is defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by the investigator using RECIST v1.1 | Safety analysis set included all participants who received ≥ 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of first dose to end of study (up to approximately 4 years and 3 months) |
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| Secondary | Clinical Benefit Rate (CBR) Assessed by IRC | CBR is defined as the percentage of participants who have CR, PR, or SD of ≥ 24 weeks in duration as assessed by the IRC using RECIST v1.1 | Safety analysis set included all participants who received ≥ 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of first dose to end of study (up to approximately 4 years and 3 months) |
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| Secondary | CBR Assessed by Investigator | CBR is defined as the percentage of participants who have CR, PR, or SD of ≥ 24 weeks in duration as assessed by the investigator using RECIST v1.1 | Safety analysis set included all participants who received ≥ 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of first dose to end of study (up to approximately 4 years and 3 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analogue Score (VAS) | Mean change from baseline in EQ-5D-5L 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. | Safety analysis set included all participants who received ≥ 1 dose of study drug; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days) |
|
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| Secondary | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status | Mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients. 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. | Safety analysis set included all participants who received ≥ 1 dose of study drug; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days) |
|
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| Secondary | EORTC QLQ - Hepatocellular Carcinoma 18 Questions (HCC18): Index Scores | Mean change from baseline in EORTC QLQ HCC18 Index Scores. The EORTC QLQ HCC18 is a specific questionnaire module that assesses quality of life of cancer patients 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. | Safety analysis set included all participants who received ≥ 1 dose of study drug; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days) |
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| Secondary | Number of Participants With Adverse Events | 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 | Safety analysis set included all participants who received ≥ 1 dose of study drug | Posted | Number | Participants | From first dose up to 30 days after the last dose of study drug; up to approximately 4 years and 3 months |
|
|
From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tislelizumab | Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first | 180 | 249 | 94 | 249 | 226 | 249 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Primary adrenal insufficiency | Endocrine disorders | meddra 24.0 | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | meddra 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Haemoperitoneum | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Death | General disorders | meddra 24.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Budd-Chiari syndrome | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Hepatic artery aneurysm | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Hepatorenal syndrome | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Intracranial tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Neoplasm swelling | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| VIth nerve paralysis | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Superior vena cava occlusion | Vascular disorders | meddra 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | meddra 24.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Total bile acids increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra 24.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra 24.0 | Systematic Assessment |
|
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | 1-877-828-5568 | clinicaltrials@beigene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 8, 2020 | Jul 3, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
Not provided
Not provided
Not provided
| Other |
|
| Not Reported |
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