Impact of Radiotherapy on ctDNA in Patients With Hepatocellular Carcinoma
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 antit
| Condition(s) | HCC - Hepatocellular Carcinoma |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 pre |
| Who can participate | Inclusion Criteria: * Patients aged ≥ 18 years old * Eastern Cooperative Oncology Group (ECOG) performance 0 to 1 * Confirmed diagnosis of Hepatocellular carcinoma (HCC) * Tumour size ≥ 3cm * Patients planning on undergoing Stereotactic Body Radiation Therapy (SBRT) for HCC * Prior radiofrequency ablation at a different site, or prior surgery are eligible * Child-Pugh A liver function * Life expectancy longer than 12 weeks * At least one measurable treatment lesion according to RECIST 1.1 * Written informed consent must be obtained prior to any study related procedures * Adequate haematological function (Hemoglobin ≥ 8.5g/dL; Platelet Count ≥ 75x109/L; Antenatal Care ≥ 1.5x109/L; international normalised ratio ≤ 1.5) * Adequate hepatic function (albumin ≥ 28g/l; Bilirubin ≤ 1.5xULN; Alanin |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Chinese University of Hong Kong |
| Locations | Hong Kong, Hong Kong |
| Start date | 2025-04-08 |
| NCT ID | NCT06885879 |
| Official listing | https://clinicaltrials.gov/study/NCT06885879 |