Impact of Radiotherapy on the Dynamic Changes of Circulating Cell-free DNA in Patients With Hepatocellular Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Radiation
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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; Alanine transaminase \< 5 times upper limit normal)

• Adequate renal function (serum creatinine ≤ 1.5 times the upper limit of normal range; Sodium ≥ 130mmol/L; Potassium ≥ 3.0mmol/L)

• Able to read, understand and provide written consent

Locations
Other Locations
Hong Kong Special Administrative Region
Department of Clinical Oncology, Prince of Wales Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Landon L CHAN, MSc, MBChB
landon.chan@cuhk.edu.hk
+852 3505 1042
Backup
Natalie KWONG
nataliekwong019@cuhk.edu.hk
+852 3505 1040
Time Frame
Start Date: 2025-04-08
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 15
Treatments
Temporal change of fragmentomics of Circulating tumour DNA investigation
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov

Similar Clinical Trials