NCT07305428Recruiting
Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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 current 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 12 Dec 2025
- Start date
- 25 Apr 2019
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- The University of Hong Kong
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07305428
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 25 Apr 2019 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy to the region of liver or selective internal radiotherapy
Other illness
- Prior invasive malignancy
- Main portal vein or inferior vena cava (IVC) thrombosis or involvement
Other
- Severe, active co-morbidity
- Presence of extra-hepatic metastases (M1)
- Presence of ascites or encephalopathy
- Contraindicated of SBRT:
- Any one hepatocellular carcinoma \> 15 cm
- Total maximal sum of hepatocellular carcinoma \> 25 cm
- More than 3 discrete hepatic nodule
- Direct tumor extension into the stomach, duodenum, small bowel, large bowel, common or main branch of biliary tree
Who the study is looking for
- Diagnosis of HCC is made according to American Association for the Study of Liver Diseases (AASLD) practice guideline 2010: patients with cirrhosis of any etiology and patients with chronic hepatitis B (HBV) who may not have fully developed cirrhosis, the presence of liver nodule \>1cm and demonstrated in a single contrast enhanced dynamic imaging \[either computed tomography (CT) or magnetic resonance imaging (MRI)\] of intense arterial uptake and "washout" in portal venous and delayed phases.
- Tumor size 5-25 cm or number of lesions ≤3 or segmental portal vein involvement
- Age: 18-80 years old
- Child Pugh liver function class A-B7
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.