Study of BGB-A317 in Participants With Previously Treated Unresectable HCC

October 23, 2024 updated by: BeiGene

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
249

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • The Second Hospital of Anhui Medical University
      • Hefei, Anhui, China, 230000
        • Anhui Provincial Hospital
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital
      • Beijing, Beijing, China, 100039
        • Military Hospital of China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 510245
        • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
      • Shenzhen, Guangdong, China, 518036
        • Peking University Shenzhen Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430022
        • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Xuzhou Central Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The Second Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University Branch Donghu
    • Jilin
      • Changchun, Jilin, China, 130021
        • Jilin Cancer Hospital
    • Shandong
      • Weifang, Shandong, China, 261000
        • Weifang Peoples Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai, China, 200032
        • Affiliated Zhongshan Hospital of Fudan University
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310003
        • The first Affiliated Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310009
        • Zhejiang University College of Medicine Second Affiliated Hospital
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
  • France
      • Clichy, France, 92210
        • Hôpital Beaujon
      • Lyon, France, 69317
        • Hopital de la croix rousse
      • Montpellier Cedex, France, 34295
        • Chu Montpellier Hopital Saint Eloi
      • Nantes Cedex, France, 44093
        • Centre Hospitalier Universitaire Nantes Hotel Dieu
      • Nice, France, 6200
        • Hopital Larchet Chu Nice
      • Pessac Cedex, France, 33604
        • Groupe Hospitalier Du Haut Leveque
      • Poitiers, France, 86000
        • Chu de Poitiers Site de La Mileterie
      • Rennes, France, 35043
        • Centre Eugene Marquis
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Essen, Germany, 45136
        • Kliniken Essen Mitte Evang Huyssens Stiftung
      • Hamburg, Germany, 20251
        • Universitätsklinikum Hamburg Eppendorf
      • Mainz, Germany, 55131
        • Klinikum Johannes Gutenberg Universitaet Mainz
  • Italy
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
  • Poland
      • Warszawa, Poland, 02-034
        • Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall dHebron
      • Barcelona, Spain, 08908
        • Ico Lhospitalet Hospital Duran I Reynals
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28050
        • Hospital Universitario Hm Madrid Sanchinarro
  • Taiwan
      • Kaohsiung, Taiwan, 82445
        • E Da Hospital Kaohsiung
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Greater Manchester, United Kingdom, M20 4BX
        • The Christie Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital London Nhs Trust
      • London, United Kingdom, SE5 9RS
        • Kings College
      • NewCastle Upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Histologically confirmed HCC
  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

Key Exclusion Criteria:

  1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
  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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tislelizumab
200 milligrams once every 3 weeks
Drug: Tislelizumab
Administered intravenously
Other Names:
  • BGB-A317

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC)
Time Frame: From date of first dose to primary analysis data cut-off date of 30-June-2021 (up to approximately 3 years and 3 months)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ORR Assessed by Investigator
Time Frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
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)
Duration of Response (DOR) Assessed by IRC
Time Frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
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
Time Frame: From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported
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
Time Frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
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
Time Frame: From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported
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
Time Frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
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
Time Frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
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)
Time Frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
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
Time Frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
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
Time Frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
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
Time Frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
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
Time Frame: From date of first dose to end of study (up to approximately 4 years and 3 months)
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)
Time Frame: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)
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
Time Frame: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)
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
Time Frame: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)
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
Time Frame: From first dose up to 30 days after the last dose of study drug; up to approximately 4 years and 3 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
From first dose up to 30 days after the last dose of study drug; up to approximately 4 years and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BeiGene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, BeiGene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BGB-A317-208
  • 2017-003983-10 (EudraCT Number)
  • CTR20171257 (Registry Identifier: Center for drug evaluation, CFDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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