Actively Recruiting
Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study
Led by The University of Hong Kong · Updated on 2025-12-26
30
Participants Needed
1
Research Sites
609 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hepatocellular carcinoma (HCC) is one of the commonest cancers worldwide and ranks the third on the incidence of cancer-related death. There are more than 500000 new cases diagnosed annually worldwide. The incidence and prevalence of HCC are on rising trend with the majority of the disease burden is in Asia where viral hepatitis B is endemic. Surgical resection, radiofrequency ablation (RFA) and liver transplantation (LT) represent the only chance of cure for HCC patients. Despite more aggressive surgical approach has been adopted in most Asian countries, yet curative intervention remains only amendable in 30% of patients. Most patients are diagnosed with intermediate or advanced stage diseases; the long-term cure rate is only 0-10%. Hence, every effort has been made in an attempt to convert inoperable HCC into operable disease (i.e. downstaging) in order to improve the chance of survival of these patients. The current study, to our knowledge, will be the first study in the field to deploy a novel treatment strategy to deploy both immunotherapy and stereotactic beamed radiotherapy to induce tumor shrinkage rendering it become operable cancer.
CONDITIONS
Official Title
Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of HCC according to AASLD 2010 guidelines with liver nodule >1 cm showing arterial uptake and washout on CT or MRI
- Tumor size between 5 and 25 cm or up to 3 lesions or segmental portal vein involvement
- Age between 18 and 80 years
- Child Pugh liver function class A or B7
- ECOG performance status score of 0 or 1
You will not qualify if you...
- History of prior invasive malignancy
- Previous radiotherapy to the liver region or selective internal radiotherapy
- Severe, active co-morbid conditions
- Presence of extra-hepatic metastases
- Thrombosis or involvement of main portal vein or inferior vena cava
- Presence of ascites or encephalopathy
- Contraindications to stereotactic body radiation therapy including:
- Any HCC tumor larger than 15 cm
- Total maximum sum of HCC tumors larger than 25 cm
- More than 3 discrete liver nodules
- Direct tumor extension into stomach, duodenum, small bowel, large bowel, or main biliary branches
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Queen Mary Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
A
Albert Chan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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