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New treatment option for HCC
Official title SBRT in HCC With Oligoprogression on First-line Immunotherapy
ClinicalTrials.gov ID: NCT06434480
What this study is testing
- What it's testing
- HCC is a huge healthcare burden in Hong Kong and is one of the top 5 cancers in terms of incidence and mortality in Hong Kong. Patients with advanced HCC are treated with immunotherapy-based as first-line treatment as a standard of care.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged ≥ 18 years old
- ECOG performance 0 to 1
- Confirmed diagnosis of HCC
- Oligoprogression on first-line immunotherapy, as defined as ≤ 5 lesions (intra- and extrahepatic lesions all together; vascular tumor thrombus is...
- First-line immunotherapy that are allowed in this study include atezolizumab plus bevacizumab, durvalumab plus tremelimumab, durvalumab, nivolumab...
You likely can't join if
- History of another malignancy except appropriately-treated BCC of skin or CIN of cervix during the last 5 years
- 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
See the full eligibility criteria
- Patients aged ≥ 18 years old
- ECOG performance 0 to 1
- Confirmed diagnosis of HCC
- Oligoprogression on first-line immunotherapy, as defined as ≤ 5 lesions (intra- and extrahepatic lesions all together; vascular tumor thrombus is counted as one lesion)
- First-line immunotherapy that are allowed in this study include atezolizumab plus bevacizumab, durvalumab plus tremelimumab, durvalumab, nivolumab and ipilimumab, which are approved by the FDA and have been used in Hong...
- Progressed lesion(s) amenable to SBRT:
- For intrahepatic progression:
- Number of intrahepatic progression ≤ 5
- Total intrahepatic tumours ≤ 10
- Maximum sum of HCC ≤ 20cm
- Any one HCC ≤ 20cm
- Normal liver volume minus intrahepatic GTV \> 700cc
- Mean liver dose ≤ 15Gy
- No measurable common or main branch biliary duct involvement
- No direct tumor invasion into the stomach, duodenum, small bowel or large bowel
- For extrahepatic progression:
- Maximal tumor size ≤ 7cm
- Respective dose constraints of organ at risks as listed on the UK 2022 Consensus on Normal Tissue Dose-Volume Constraints for Oligometastatic, Primary Lung and Hepatocellular Carcinoma Stereotactic Ablative Radiotherapy...
- Prior radiofrequency ablation (RFA) or trans-arterial chemoembolization (TACE) 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 (Hb ≥ 8.5g/dL; Plt ≥ 50x10\^9/L; ANC ≥ 1.0x10\^9/L; INR ≤ 1.5)
- Adequate hepatic function (albumin ≥ 28g/L; Bilirubin ≤ 2.5xULN; ALT \< 5 times upper limit normal)
- Adequate renal function (serum creatinine ≤ 1.5 times the upper limit of normal range; Na ≥ 130mmol/L; K ≥ 3.0mmol/L)
- Able to read, understand and provide written consent
- History of another malignancy except appropriately-treated BCC of skin or CIN of cervix during the last 5 years
- 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 HIV)
- Ongoing corticosteroid therapy \>10mg prednisone daily
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.