Durvalumab for Advanced Hepatocellular Carcinoma in Patients With Active Chronic Hepatitis B Virus Infection
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
PD1 blockade has been approved as salvage therapy for advanced hepatocellular carcinoma
(HCC). Although there is not solid evidence that PD1 blockade would induce hepatitis B virus
(HBV) reactivation, previous clinical trials of PD1 blockade required enrolled patients to
receive anti-HBV medications and control the viral load to be under 100-2000 IU/mL before
initiation of PD1 blockade therapy. Such a requirement may not be necessary and could delay
the treatment. Guidelines for prevention of chemotherapy induced HBV reactivation only
suggest combining anti-HBV medications during the chemotherapy course without such a
requirement of very load HBV viral load.
The investigators hypothesized that under anti-HBV medications, patients with advanced HCC
and active chronic hepatitis B virus (HBV) infection can receive durvalumab treatment without
increased risks of HBV reactivation and related complications.
Phase:
Phase 2
Details
Lead Sponsor:
National Taiwan University Hospital
Collaborators:
AstraZeneca Ministry of Science and Technology, Taiwan, ROC