Effects of radiotherapy on circulating tumor DNA in liver cancer patients
Impact of Radiotherapy on the Dynamic Changes of Circulating Cell-free DNA in Patients With Hepatocellular Carcinoma
This study is testing how Stereotactic Body Radiation Therapy affects levels of tumor DNA in the blood of liver cancer patients to see if it can help track how well the treatment is working.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06885879 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of Stereotactic Body Radiation Therapy (SBRT) on circulating tumor DNA (ctDNA) in patients diagnosed with hepatocellular carcinoma (HCC). The study aims to explore how ctDNA levels change over time following radiotherapy, which could provide a more dynamic and frequent method for assessing treatment response compared to traditional imaging techniques. By monitoring ctDNA, researchers hope to establish a better understanding of the timing for response assessment after radiotherapy. This approach could potentially lead to improved management strategies for HCC patients undergoing SBRT.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of hepatocellular carcinoma, planning to undergo Stereotactic Body Radiation Therapy.
Not a fit: Patients with advanced liver dysfunction or those not eligible for SBRT may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable blood-based biomarker for monitoring treatment response in liver cancer patients, leading to more personalized treatment plans.
How similar studies have performed: While the use of ctDNA as a biomarker is emerging, this specific approach in the context of SBRT for HCC is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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; 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 Exclusion Criteria: * 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 * Previous yttrium-90 chemoembolization * Repetitive history of non-healing wounds or ulcers within 2 months of inclusion * Pregnant or lactating females at any time during the study * Active autoimmune disease requiring systemic therapy in the past 2 years * Diagnosis of immunodeficiency (including Human Immunodeficiency Viruses) * Patients with coagulopathy or on anticoagulant will be excluded from liver biopsy
Where this trial is running
Hong Kong
- Department of Clinical Oncology, Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Landon L CHAN, MSc, MBChB
- Email: landon.chan@cuhk.edu.hk
- Phone: +852 3505 1042
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.