Study of BGB-A317 in Participants With Previously Treated Unresectable HCC
A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma
3 other identifiers
interventional
249
8 countries
54
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2018
Typical duration for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedStudy Start
First participant enrolled
April 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2022
CompletedResults Posted
Study results publicly available
July 27, 2023
CompletedOctober 26, 2024
October 1, 2024
3.2 years
January 29, 2018
July 3, 2023
October 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (16)
ORR Assessed by Investigator
From date of first dose to end of study (up to approximately 4 years and 3 months)
Duration of Response (DOR) Assessed by IRC
From date of first dose to end of study (up to approximately 4 years and 3 months)
DOR Event-Free Rate Assessed by IRC
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
From date of first dose to end of study (up to approximately 4 years and 3 months)
DOR Event-Free Rate Assessed by Investigator
From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported
- +11 more secondary outcomes
Study Arms (1)
Tislelizumab
EXPERIMENTAL200 milligrams once every 3 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed HCC
- 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
- Has received at least 1 line of systemic therapy for unresectable HCC
- Has at least 1 measurable lesion as defined per RECIST v1.1
- Child-Pugh score A
- Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function
You may not qualify if:
- 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:
- 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
- Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (54)
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
The Second Hospital of Anhui Medical University
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 District, 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
Related Publications (2)
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.
PMID: 36872927BACKGROUNDSerrano 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.
PMID: 34518988BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2018
First Posted
February 5, 2018
Study Start
April 9, 2018
Primary Completion
June 30, 2021
Study Completion
July 6, 2022
Last Updated
October 26, 2024
Results First Posted
July 27, 2023
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share