Impact of Radiotherapy on ctDNA in Patients With Hepatocellular Carcinoma

Phase: II

Sponsor: Chinese University of Hong Kong

Responsible party: Dr. Landon Chan, Chinese University of Hong Kong

  • Clinical Trial Summary

    Radiotherapy is an effective treatment for liver cancer, but it often takes months before scans can clearly show whether the treatment has worked, as imaging changes may persist even after cancer cells are destroyed. This study aims to find a faster and clearer way to monitor treatment response using a simple blood test. By tracking specific features of this circulating tumour DNA before and after radiotherapy, researchers hope to see whether blood changes can indicate treatment response earlier than scans.

  • What Happens During The Study

    Participants will have blood drawn (~20 ml each time) at:

    • Before SBRT
    • During treatment (Week 1)
    • After treatment (Week 2)
    • 3 months after treatment
    • 6 months after treatment

    Scans and follow-up:

    • Imaging scans (like CT/MRI) will also be done before treatment, then at 3 and 6 months to compare with blood results.

    There is no experimental drug. this study only observes how things change with normal treatment.

  • Trial started

    8 April 2025

  • Trial ended (estimated)

    31 July 2027

  • Trial method

    Observational

  • Number of participants

    15

  • Month 1

    Week 1

    • CT/MRI scan before SBRT treatment
    • Participants will get SBRT treatment and have the blood drawn for the first time

    Week 2

    • Regular checkup, the second blood drawn
  • Month 3

    • Regular checkup, the third blood test
    • CT/MRI scan
  • Month 6

    • Regular checkup, the final blood test
    • CT/MRI scan
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Eligibility criteria:

You may be eligible if you:

  • Are 18 years or older
  • Are generally well and able to carry out normal daily activities (ECOG 0–1)
  • Have a confirmed diagnosis of liver cancer (hepatocellular carcinoma)
  • Have a liver tumour 3 cm or larger
  • Are planning to receive Stereotactic Body Radiation Therapy (SBRT) for liver cancer
  • May have had previous liver surgery or radiofrequency ablation, as long as it was at a different site
  • Have well-preserved liver function (Child-Pugh A)
  • Are expected to live longer than 12 weeks
  • Have at least one tumour that can be measured on scans
  • Have adequate blood, liver, and kidney function, based on routine blood tests
  • Are able to read, understand, and sign a written consent form

Exclusion criteria:

You may not be eligible if you:

  • Have a rare subtype of liver cancer or a mixed liver cancer diagnosis
  • Have had another type of cancer within the past 5 years
  • Received TACE treatment within the last 3 months
  • Have previously had radiotherapy to the abdomen
  • Have undergone yttrium-90 (Y-90) radioembolization
  • Have a recent history of poor wound healing or chronic ulcers
  • Are pregnant or breastfeeding
  • Have an active autoimmune disease requiring immune-suppressing treatment in the past 2 years
  • Have a known immune system disorder, including HIV
  • Have a bleeding disorder or are taking blood-thinning medication that makes liver biopsy unsafe