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Study identifier: NCT03899428 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Immune Checkpoint Therapy vs Target Therapy in Reducing Serum HBsAg Levels in Patients With HBsAg+ Advanced Stage HCC

Condition: Hepatocellular Carcinoma  ·  Sponsor: Humanity & Health Medical Group Limited

PhasePhase 2
Planned participants30
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

It is estimated that over 50% of HCC cases worldwide are related to chronic HBV. There are approximately 350-400 million people across the world infected with HBV, the majority reside in or originate from Asia. Each year HBV accounts for 749,000 new cases of HCC and 692,000 HCC-related deaths. The annual incidence of HCC is estimated to be \<1% for non-cirrhotic HBV infected patients and 2-3% for those with cirrhosis. While the most approved nucleos(t)ide analogues (NA) suppress HBV replication through inhibition of HBV-DNA polymerase and are reported to reduce the risk of HCC incidence, however, such risk is not completely eliminated under NA treatment. The recent availability of commercial quantitative assays of serum hepatitis B surface antigen (HBsAg) has enabled quantitative HBsAg to be used as a biomarker for prognosis and treatment response in CHB. It has been suggested that HBsAg decline during lamivudine or entecavir therapy is slower and less pronounced compared to interferon treatment, despite a higher effect on HBV DNA suppression. Based on HBsAg kinetics, it has been estimated that the predicted median time to HBsAg loss in patients treated with lamivudine or entecavir is more than 30 years. Thus, treatment that can induce rapid decline of HBsAg would have clear advantage in reducing the treatment duration required to achieve HBsAg-loss. Interestingly, in a recent preliminary study, 12-weeks of treatment with nivolumab has showed the modest effect on HBsAg decl…

This description comes directly from the study's public registry record.

Talk to the study team

George Lau, MD  ·  +852-28613777  ·  gkklau@netvigator.com

Danny Wang, PhD  ·  +852-28613777  ·  danny.wang@hnhmgl.com

Always discuss trial participation with your own doctor first.

Locations (1)

Humanity & Health Research CentreHong Kong, Hong Kong SAR, Hong KongRecruiting

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Source record: clinicaltrials.gov/study/NCT03899428