TACE and SBRT Followed by Double Immunotherapy for Downstaging Hepatocellular Carcinoma

Phase: II

Sponsor: The University of Hong Kong

Responsible party: The University of Hong Kong

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  • Clinical Trial Summary

    This clinical trial is evaluating a new treatment approach for people with liver cancer that cannot be removed by surgery. Many patients are diagnosed when tumors are too large or advanced for curative treatment, and standard therapies often control the disease without eliminating it. In this study, doctors first treat the liver tumors locally by cutting off their blood supply (TACE) and using highly precise radiation (SBRT), then follow with immunotherapy drugs that help the immune system recognize and attack cancer cells. The aim is to safely shrink and control the tumors, improve outcomes and quality of life, and, for some patients, make surgery or other curative treatments possible.

  • What Happens During The Study

    Participants will receive a combination of immunotherapy and targeted liver treatment over several weeks.

    • Week 0–1: Trans-arterial chemoembolization (TACE) is performed first. A catheter is guided into the blood vessels feeding the liver tumor to deliver chemotherapy directly to the tumor and block its blood supply. Patients are monitored in hospital and usually discharged within a few days.
    • Week 2–4: Stereotactic body radiotherapy (SBRT) planning and treatment. This includes a planning CT scan followed by several highly focused radiation sessions over 1–2 weeks, designed to precisely target the tumor while sparing healthy liver tissue.
    • Week 4 (Cycle 1, Day 1): Immunotherapy starts. Patients receive durvalumab (IV infusion over ~60 minutes) together with a single dose of tremelimumab (IV infusion over ~60 minutes).
    • Every 4 weeks up to 3 years: Durvalumab maintenance infusions continue once every 4 weeks.

    Treatment continues as long as the cancer is controlled and side effects remain manageable.

  • Trial started

    1 December 2020

  • Trial ended (estimated)

    1 December 2026

  • Trial method

    Interventional

  • Number of participants

    33

Clinical Trial Timeline

  • Month 1

    Week 0 - 1:

    • 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
    • Trans-arterial chemoembolization (TACE).

    Week 2 - 4:

    • Stereotactic body radiotherapy (SBRT) planning and treatment

  • Month 2 - 60

    Week 4 (cycle 1):

    • Durvalumab/MEDI4736 1500 mg administered IV and 300mg Tremelimumab infusions

    Week 8 - 60 (every 4 weeks):

    • Durvalumab/MEDI4736 1500 mg administered IV infusions
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Eligibility criteria:

You may be eligible if you:

  • Are 18 years or older and able to provide written informed consent.
  • Have a confirmed diagnosis of hepatocellular carcinoma (liver cancer) that is not suitable for surgery at the time of enrollment.
  • Have disease limited to the liver, with no spread to other organs.
  • Have good general health and daily functioning.
  • Have adequate liver, kidney, and bone marrow function based on blood tests.
  • Have one to three liver tumors, with each tumor measuring between 5 cm and 25 cm, and a total combined tumor size of no more than 30 cm, located in areas of the liver where SBRT can be safely delivered.
  • Have not received prior immunotherapy.
  • Have well-controlled hepatitis B, if present, with appropriate antiviral treatment.
  • Are willing and able to comply with hospital visits, treatments, scans, and follow-up assessments.

Exclusion criteria:

You may not be eligible if you:

  • Have cancer that has spread outside the liver, including to the brain.
  • Have severe liver impairment, uncontrolled fluid in the abdomen (ascites), or hepatic encephalopathy.
  • Have received previous radiotherapy to the liver or treatments that conflict with this study.
  • Have an active autoimmune or inflammatory disease requiring immune-suppressing treatment.
  • Have an active or uncontrolled infection, such as hepatitis, tuberculosis, or HIV.
  • Have had major surgery recently or are currently receiving another cancer treatment or participating in another interventional study.
  • Are pregnant or breastfeeding, or not willing to use effective contraception during and after treatment.
  • Have tumors that are too large, too numerous, or located too close to critical organs, making SBRT unsafe.
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Clinical Trial Location

Department of Surgery, The University of Hong Kong (HKU)

Contacts:

Sub-Investigator: