About this trial
Radiotherapy is increasingly being used in the management of hepatocellular carcinoma (HCC) as a standalone treatment, or in combination with systemic therapy. Stereotactic Body Radiation Therapy (SBRT) causes cell death directly (via double-stranded breaks) and indirectly (via vascular bed damage or promotion of antitumour immunity). Unfortunately, the effect of cell death is not immediate and takes time. As a result, the typical arterial phase hyperenhancement on imaging may persist up to 12 months after radiotherapy, and it is not necessarily suggestive of presence of viable tumours. Therefore, there is no consensus on ideal timing of response assessment following radiotherapy to HCC. Therefore, a blood-based biomarker which can be done frequently and monitored dynamically, could be preferred for response assessment after radiotherapy. Circulating tumour DNA (ctDNA) is an emerging and promising biomarker in cancer management, which has been shown useful in cancer screening, guiding treatment, and informing prognosis. Currently, most of the clinical applications of ctDNA revolve around either the presence of ctDNA, or the genomic changes associated with these molecules. Biological properties of ctDNA such as fragment length, jaggedness of fragments, or epigenetic changes may provide additional information related to the tumour characteristics and its sensitivity to anti-cancer treatments. These biological properties of ctDNA are relatively unexplored in the context of radiotherapy. It is unknown whether these properties can be utilized for monitoring treatment response. We therefore propose to study the biological properties of ctDNA in relation to HCC patients undergoing radiotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥ 18 years old
Eastern Cooperative Oncology Group (ECOG) performance 0 to 1
Confirmed diagnosis of Hepatocellular carcinoma (HCC)
Tumour size ≥ 3cm
Disqualifiers
Histology shows sarcomatoid HCC, fibrolamellar HCC, mixed cholangiocarcinoma-hepatocellular carcinoma
Presence of other malignancy than HCC within 5 years from diagnosis of HCC
Prior Transarterial chemoembolization (TACE) within 3 months
Previous radiotherapy to the abdomen
Trial population
Patients with hepatocellular carcinoma
Trial design
Case-only
Prospective
Treatments tested in this trial
Temporal change of fragmentomics of Circulating tumour DNA undergoing Stereotactic Body Radiation Therapy investigation
RadiationPatients will have blood taking for Circulating tumour DNA (ctDNA) (20cc each) at Week 0 (before radiotherapy), Week 1 (during radiotherapy), Week 2 (after radiotherapy), Week 12 and Week 24. Radiological assessment will be performed before radiotherapy, Week 12 (approximately 3 months post treatment) and Week 24-26 (approximately 6 months post treatment).
Treatment groups
Trial outcomes
Primary outcomes
To characterize the temporal changes of the biological properties of Circulating tumour DNA, including its relative percentage, fragment size, and end-motif fragment pattern for patients undergoing radiotherapy to Hepatocellular carcinoma.
Secondary outcomes
To correlate the change in biological properties with response (by RECIST 1.1), survival (e.g. progression-free survival), and toxicities
Sponsors and contacts
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