18 and older, any sex, with Hepatocellular Carcinoma (HCC). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC)Primary· 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.
Group
Value
95% CI
Tislelizumab
12.9
8.96 – 17.66
ORR Assessed by InvestigatorSecondary· 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.
Group
Value
95% CI
Tislelizumab
14.5
10.34 – 19.45
Duration of Response (DOR) Assessed by IRCSecondary· 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
Group
Value
95% CI
Tislelizumab
NA
14.6 – NA
DOR Event-Free Rate Assessed by IRCSecondary· 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.
12 Months
Group
Value
95% CI
Tislelizumab
76.9
57.5 – 88.3
24 Months
Group
Value
95% CI
Tislelizumab
65.9
45.7 – 80.1
DOR Assessed by InvestigatorSecondary· 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
Group
Value
95% CI
Tislelizumab
21.4
11.1 – NA
DOR Event-Free Rate Assessed by InvestigatorSecondary· 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.
12 Months
Group
Value
95% CI
Tislelizumab
68.1
49.8 – 80.9
24 Months
Group
Value
95% CI
Tislelizumab
47.4
30.1 – 62.8
Progression-free Survival (PFS) Assessed by IRCSecondary· 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
Group
Value
95% CI
Tislelizumab
2.7
1.4 – 2.8
PFS Assessed by InvestigatorSecondary· 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
Group
Value
95% CI
Tislelizumab
2.8
2.6 – 4.0
Overall Survival (OS)Secondary· 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
Group
Value
95% CI
Tislelizumab
13.2
10.8 – 15.2
Disease Control Rate (DCR) Assessed by IRCSecondary· 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
Group
Value
95% CI
Tislelizumab
53.0
46.61 – 59.34
DCR Assessed by InvestigatorSecondary· 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
Group
Value
95% CI
Tislelizumab
59.0
52.65 – 65.20
Clinical Benefit Rate (CBR) Assessed by IRCSecondary· 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
Group
Value
95% CI
Tislelizumab
22.5
17.46 – 28.19
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months).
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer
· Phase 2
· not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence
· Phase 3
· not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure
· Phase 2
· recruiting
NCT07290985 — AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas
· Phase 2
· not yet recruiting
NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin
· Phase 2
· not yet recruiting
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BeiGene
Last refreshed: 26 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03419897.