Status:
COMPLETED
Study of BGB-A317 in Participants With Previously Treated Unresectable HCC
Lead Sponsor:
BeiGene
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Key
- 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
- 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
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
April 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2022
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT03419897
Start Date
April 9 2018
End Date
July 6 2022
Last Update
October 26 2024
Active Locations (54)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
2
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
3
Military Hospital of China
Beijing, Beijing Municipality, China, 100039
4
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142