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

Phase: III

Sponsor: Humanity & Health Medical Group Limited

Responsible party: Humanity & Health Medical Group Limited

  • Clinical Trial Summary

    Chronic hepatitis B is a major cause of liver cancer worldwide, especially in Asia, and while current antiviral medications can control the virus and lower cancer risk, they rarely eliminate it completely, meaning patients often need lifelong treatment and still face ongoing liver damage.

    This study is being done because new immune-based treatments may help the body clear the virus more effectively: standard drugs suppress the virus but can take decades to reduce key viral markers, whereas early research suggests immune checkpoint therapy may speed up this process by strengthening the body’s own immune response.

    By comparing immune therapy with standard targeted treatments in patients with advanced liver cancer and hepatitis B, researchers aim to see whether immune therapy can reduce the virus more quickly, potentially shortening treatment duration and improving long-term liver health.

  • What Happens During The Study

    Participants will take part in the study over a period of up to 2 years, following a structured timeline designed to closely monitor treatment effects and safety.

    Screening (before treatment starts):

    • Blood tests, CT or MRI scans, and medical history review to confirm eligibility.

    Treatment period (up to 2 years):

    • Immune checkpoint therapy group: Durvalumab given by intravenous infusion every 4 weeks.
    • Targeted therapy group: Daily oral targeted cancer medication, prescribed by participant's personal doctor.

    Regular follow-up visits:

    • Throughout treatment, participants will have scheduled clinic visits for blood tests (including hepatitis B markers), imaging scans to assess the tumour, and discussions about the health condition in general.

    Safety monitoring:

    • Participants are continuously monitored for side effects and overall treatment tolerance from the start of treatment through the follow-up period.
  • Trial started

    2 May 2019

  • Trial ended (estimated)

    31 December 2025

  • Trial method

    Interventional

  • Number of participants

    30

  • Month 1

    Week 0:

    • Review of medical history and current hepatitis B treatment (e.g., entecavir/tenofovir/TAF)
    • Blood tests (HBsAg level, liver/kidney function, blood counts, INR)
    • CT or MRI scan to measure tumour(s) at baseline

    Week 1 - 4:

    • Immune checkpoint therapy arm: Durvalumab IV infusion every 4 weeks (first dose around Week 1)
    • Targeted therapy arm: Oral targeted therapy daily
    • Clinic visit(s) + blood tests to check safety and hepatitis B markers
  • Month 2 - 24

    • Immune therapy arm: Durvalumab infusion continues every 4 week
    • Targeted therapy arm: Continue daily tablets (dose may be adjusted if needed)
    • Regular monitoring throughout: Blood tests (including HBsAg), CT/MRI scans to track tumour response, side-effect checks and supportive care
    • Follow-up continues until study end (up to 2 years) or earlier if treatment is stopped for medical reasons
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Eligibility criteria:

You may be eligible if you:

  • Are age 18 or older
  • Have chronic hepatitis B infection, with detectable hepatitis B surface antigen (HBsAg)
  • Have been diagnosed with liver cancer (hepatocellular carcinoma) confirmed by biopsy or imaging
  • Have advanced-stage liver cancer (BCLC stage B not suitable for local treatment, or stage C)
  • Good overall physical condition, able to carry out daily activities (ECOG 0–1)
  • Liver function is stable (Child-Pugh class A or B)
  • Currently receiving standard hepatitis B antiviral treatment (such as entecavir, tenofovir, or TAF)
  • At least one measurable liver tumour visible on CT or MRI
  • Adequate blood, liver, and kidney function based on lab tests
  • Able to understand the study and provide written informed consent

Exclusion criteria:

You may not be eligible if you:

  • Have a rare type of liver cancer (such as fibrolamellar carcinoma or mixed liver–bile duct cancer)
  • Recent radiation therapy, radioembolisation, or major surgery that has not fully healed
  • Previous treatment with interferon for hepatitis B
  • Uncontrolled heart disease, recent stroke, heart attack, or serious blood clots
  • Significant bleeding risk, active internal bleeding, or untreated high-risk oesophageal varices
  • Moderate to severe fluid build-up in the abdomen (ascites)
  • Active serious infections (such as HIV) or other major uncontrolled medical conditions
  • Unable to swallow oral medications
  • Known allergy to study drugs
  • Pregnant or breastfeeding
  • Another active cancer diagnosed within the past 2 years (with limited exceptions)

Clinical Trial Location