Impact of Radiotherapy on ctDNA in Patients With Hepatocellular Carcinoma
Recruiting
Observational Study
HCC - Hepatocellular Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
15 (estimated)
Sponsor
Chinese University of Hong Kong · Other
Who this trial is looking for
This trial is looking for adults with liver cancer who are planning to receive radiation therapy. Participants will take part in monitoring their cancer response through blood tests.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with hepatocellular carcinoma.
My tumor is at least 3 cm in size.
I am planning to receive Stereotactic Body Radiation Therapy.
I have a life expectancy longer than 12 weeks.
I can read, understand, and provide written consent.
I have adequate liver, kidney, and blood function.
You may not be able to join if
I have a type of liver cancer that is not hepatocellular carcinoma.
I have had another cancer within the last 5 years.
I received Transarterial chemoembolization in the last 3 months.
I have had previous radiation therapy to my abdomen.
I have repetitive non-healing wounds or ulcers in the last 2 months.
I am pregnant or breastfeeding.
I have an active autoimmune disease needing treatment in the last 2 years.
I have a diagnosis of immunodeficiency.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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 ta…
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.
Trial Locations
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Eligibility 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 a…
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
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