Impact of Radiotherapy on ctDNA in Patients With Hepatocellular Carcinoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Temporal change of fragmentomics of Circulating tumour DNA undergoing Stereotactic Body Radiation Therapy investigation

    Radiation

    Patients 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

15 Participants
are divided into 1 treatment group
Group A: Temporal change of fragmentomics of Circulating tumour DNA investigation1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

1

To correlate the change in biological properties with response (by RECIST 1.1), survival (e.g. progression-free survival), and toxicities

Time frame
2 years

Other outcomes

Sponsors and contacts

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