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

Inclusion Criteria:

1. Histologically confirmed HCC

2. Patients 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:

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,
acute lung diseases, etc

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. Patient 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