Studies blood DNA changes in liver cancer patients receiving radiotherapy

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with hepatocellular carcinoma (liver cancer) who plan to have Stereotactic Body Radiation Therapy (SBRT) and have good liver function.

Age

18 years or older

Sex

All sexes can join

Disease stage

Confirmed hepatocellular carcinoma. Tumour size 3cm (1.2 in) or larger. At least one lesion that can be measured by RECIST 1.1. Child-Pugh A liver function. ECOG performance status 0 to 1. Life expectancy longer than 12 weeks.

Earlier treatment

Must plan to have SBRT for HCC. Earlier radiofrequency ablation at a different site, or earlier surgery, is allowed. No transarterial chemoembolization (TACE) within 3 months, no radiotherapy to the abdomen before, no yttrium-90 chemoembolization before.

Main reasons for not taking part

• Sarcomatoid HCC, fibrolamellar HCC or mixed cholangiocarcinoma-hepatocellular carcinoma
• Another cancer besides HCC within 5 years of the HCC diagnosis
• Pregnant or breastfeeding at any time during the study
• Active autoimmune disease needing systemic therapy in the past 2 years
• Immunodeficiency, including Human Immunodeficiency Viruses

The registry criteria, word for word

What the trial wants to find out

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.

The group in the trial

• Temporal change of fragmentomics of Circulating tumour DNA investigation

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