Study of BGB-A317 in Participants With Previously Treated Unresectable HCC
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ClinicalTrials.gov Identifier: NCT03419897 |
Recruitment Status :
Active, not recruiting
First Posted : February 5, 2018
Last Update Posted : April 24, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatocellular Carcinoma (HCC) | Drug: Tislelizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 249 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | RATIONALE-208: 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 |
Actual Study Start Date : | April 9, 2018 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | September 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Tislelizumab
200 mg once every 3 weeks (Q3W), intravenous dosing (IV)
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Drug: Tislelizumab
Anti-PD-1 ANTIBODY
Other Name: BGB-A317 |
- Objective Response Rate (ORR) assessed by Independent Review Committee (IRC) [ Time Frame: From date of enrollment up to 4 years, approximately ]
- Duration of Response (DOR) [ Time Frame: From first determination of an objective response up to 4 years, approximately ]
- Progression-free survival (PFS) [ Time Frame: From date of enrollment up to 4 years, approximately ]
- Disease Control Rate (DCR) [ Time Frame: From first dose of study treatment up to 4 years, approximately ]
- Clinical benefit rate (CBR) [ Time Frame: From first dose of study treatment up to 4 years, approximately. ]
- Overall Survival [ Time Frame: From date of enrollment up to 4 years, approximately. ]
- Percentage of participants with adverse events [ Time Frame: From date of enrollment up to 4 years, approximately. ]
- Health-Related Quality of Life (HRQoL) [ Time Frame: At screening or baseline up to 4 years, approximately ]
- Percentage of Participants With Clinically Significant Changes in Vital Signs Findings [ Time Frame: At screening or baseline up to 4 years, approximately ]
- Percentage of Participants With Clinically Significant Changes in Physical Examination Findings [ Time Frame: At screening or baseline up to 4 years, approximately ]
- Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings [ Time Frame: At screening or baseline up to 4 years, approximately ]
- Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings [ Time Frame: At screening or baseline up to 4 years, approximately ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- 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
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, acute lung diseases, etc
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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
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419897

Principal Investigator: | Ann-Lii Cheng, PhD | National Taiwan University Hospital |
Responsible Party: | BeiGene |
ClinicalTrials.gov Identifier: | NCT03419897 |
Other Study ID Numbers: |
BGB-A317-208 2017-003983-10 ( EudraCT Number ) CTR20171257 ( Registry Identifier: Center for drug evaluation, CFDA ) |
First Posted: | February 5, 2018 Key Record Dates |
Last Update Posted: | April 24, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Advanced liver cancer RATIONALE-208 |
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |