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
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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.
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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.
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Trial started
8 April 2025
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Trial ended (estimated)
31 July 2027
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Trial method
Observational
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Number of participants
15
Clinical Trial Timeline
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
Clinical Trial Location
Department of Clinical Oncology, Prince of Wales Hospital.
Contacts:
- Dr. Landon Chan MBChB, Msc, FRCR
- Natalie, Kwong
Principal Investigator: