Effects of radiotherapy on circulating tumor DNA in liver cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.