Status:
RECRUITING
Impact of Radiotherapy on ctDNA in Patients With Hepatocellular Carcinoma
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
HCC - Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Brief 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 (SBR...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 8 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06885879
Start Date
April 8 2025
End Date
July 31 2028
Last Update
April 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong