Immunotherapy and Radioembolisation for Metastatic Hepatocellular Carcinoma

Phase: II

Sponsor: The University of Hong Kong

Responsible party: The University of Hong Kong, Queen Mary Hospital

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  • Clinical Trial Summary

    This Phase II study looks at whether combining immunotherapy (immune checkpoint inhibitors) with radioembolisation can be a safe and effective first treatment for patients with previously untreated metastatic liver cancer (hepatocellular carcinoma). While standard treatment usually relies on targeted drugs, research suggests that radiation may also stimulate the immune system, sometimes causing tumours outside the treated area to shrink (known as the abscopal effect). This study aims to evaluate whether this combined approach can improve cancer control by enhancing the body’s immune response, while carefully monitoring safety.

  • What Happens During The Study

    Participants will receive immunotherapy (immune checkpoint inhibitors) together with radioembolisation, which delivers targeted radiation directly to liver tumours.

    • Week 1: Tremelimumab/Imjudo 300 mg and Durvalumab/MEDI4736 1500 mg infusions.
    • Week 2: Radioembolisation using yttrium-90 microspheres.
    • Week 5, 9, 13, 17, 21, 25: Durvalumab/MEDI4736 1500 mg infusions (7 cycles in total).

    Safety monitoring:

    • Participants will be closely monitored for treatment-related side effects and overall treatment tolerance throughout the study.

  • Trial started

    15 February 2023

  • Trial ended (estimated)

    30 June 2026

  • Trial method

    Interventional

  • Number of participants

    25

Clinical Trial Timeline

  • Month 1

    Week 1:

    • Infusions of Tremelimumab/Imjudo 300 mg and Durvalumab/MEDI4736 1500 mg

    Week 2:

    • Radioembolisation using yttrium-90 microspheres.

  • Month 2 - 6

    Week 5, 9, 13, 17, 21 (every 4 weeks)

    • Durvalumab/MEDI4736 1500 mg infusions

  • Month 7

    Week 25:

    • Durvalumab/MEDI4736 1500 mg infusion (final)
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Eligibility criteria:

You may be eligible if you:

  • Have metastatic liver cancer (hepatocellular carcinoma) confirmed by CT or MRI scans
  • Are 18 years or older
  • Are generally well enough to carry out daily activities (ECOG 0–1)
  • Are suitable to receive immunotherapy and yttrium-90 radioembolisation
  • Have had recent CT or MRI scans showing liver tumours that can be measured
  • Are able to understand the study and sign a consent form
  • Have adequate blood counts, including: white blood cells, platelets, and haemoglobin at safe levels
  • Have acceptable liver function, including bilirubin and liver enzymes within safe limits (Patients with Gilbert’s syndrome may still be eligible after doctor review)
  • Have adequate kidney function, based on standard blood or urine tests

Exclusion criteria:

You may not be eligible if you:

  • Recently took part in another experimental drug or device study
  • Have an active or severe autoimmune disease (such as lupus or severe rheumatoid conditions)
  • Have previously received immunotherapy or immune checkpoint inhibitors
  • Recently received chemotherapy or targeted cancer drugs and have not fully recovered
  • Have another active cancer that requires treatment (with some minor skin cancers excluded)
  • Have cancer spread to the lining of the brain or spinal cord
  • Have a serious active infection requiring hospital treatment
  • Have medical, psychological, or substance-related conditions that could interfere with study participation
  • Are pregnant, breastfeeding, or planning to conceive or father a child during the study period
  • Have HIV infection
  • Have untreated hepatitis B (Patients on antiviral treatment for at least one month may still be eligible)
  • Experienced severe side effects from prior radiation or immunotherapy affecting the brain or hormones
  • Require high-dose steroids or immunosuppressive medications
  • Have a known severe allergy to the study drugs
  • Had major surgery within the past 4 weeks
  • Have certain heart rhythm abnormalities on ECG testing
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Clinical Trial Locations

Department of Clinical Oncology, Queen Mary Hospital

Contacts:

Sub-Investigator:

  • Dennis Leung FRCR (Queen Mary Hospital)