Study of BGB-A317 in Participants With Previously Treated Unresectable HCC
NCT ID: NCT03419897
Last Updated: 2024-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
249 participants
INTERVENTIONAL
2018-04-09
2022-07-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tislelizumab
200 milligrams once every 3 weeks
Tislelizumab
Administered intravenously
Interventions
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Tislelizumab
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach
3. Has received at least 1 line of systemic therapy for unresectable HCC
4. Has at least 1 measurable lesion as defined per RECIST v1.1
5. Child-Pugh score A
6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
7. Adequate organ function
Exclusion Criteria
2. Prior therapies targeting PD-1 or PD-L1
3. Has known brain or leptomeningeal metastasis
4. Tumor thrombus involving main trunk of portal vein or inferior vena cava
5. Loco-regional therapy to the liver within 4 weeks before enrollment
6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, or acute lung diseases
7. Has received:
1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies
2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer
8. Active autoimmune diseases or history of autoimmune diseases that may relapse
9. 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
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Military Hospital of China
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chinese Pla General Hospital
Beijing, Beijing Municipality, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
Weifang Peoples Hospital
Weifang, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Hopital Beaujon
Clichy, , France
Hopital de La Croix Rousse
Lyon, , France
Chu Montpellier Hopital Saint Eloi
Montpellier, , France
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, , France
Hopital Larchet Chu Nice
Nice, , France
Groupe Hospitalier Du Haut Leveque
Pessac, , France
Chu de Poitiers Site de La Mileterie
Poitiers, , France
Centre Eugene Marquis
Rennes, , France
Institut Gustave Roussy
Villejuif, , France
Kliniken Essen Mitte Evang Huyssens Stiftung
Essen, , Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, , Germany
Klinikum Johannes Gutenberg Universitaet Mainz
Mainz, , Germany
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
Warsaw, , Poland
Hospital Universitario Vall Dhebron
Barcelona, , Spain
Ico Lhospitalet Hospital Duran I Reynals
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Hm Madrid Sanchinarro
Madrid, , Spain
E Da Hospital Kaohsiung
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Queen Elizabeth Hospital
Birmingham, , United Kingdom
The Christie Hospital
Greater Manchester, , United Kingdom
Royal Free Hospital London Nhs Trust
London, , United Kingdom
Kings College
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003983-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTR20171257
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-A317-208
Identifier Type: -
Identifier Source: org_study_id
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