Radiation and immunotherapy to shrink liver cancer that cannot yet be operated on
Tests radiation plus immunotherapy to make inoperable liver cancer operable in adults.
Key facts
- Who runs it
- The University of Hong Kong
- Where
- Hong Kong, Hong KongSee the site
- Trial code
- Registry title
- Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 25 Apr 2019
- Expected to end
- 31 Dec 2030
- Type of study
- Interventional
- Treatments tested
- Stereotactic Body Radiation Therapy followed by Immunotherapy
- Record updated
- 28 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with liver cancer (hepatocellular carcinoma) that cannot be removed by surgery now. The aim is to shrink it with immunotherapy and focused radiotherapy so surgery becomes possible.
- Age
- 18-80 years old
- Sex
- All sexes can join.
- Disease stage
- Hepatocellular carcinoma (HCC) confirmed by imaging, with tumor size 5-25 cm (2–9.8 in) or up to 3 lesions or segmental portal vein involvement. Liver function Child Pugh class A-B7. ECOG performance status 0 or 1.
- Earlier treatment
- No prior radiotherapy to the liver region and no selective internal radiotherapy.
Main reasons for not taking part
- Prior invasive cancer
- Cancer spread outside the liver (extra-hepatic metastases)
- Tumor or clot in the main portal vein or inferior vena cava (IVC)
- Ascites or encephalopathy
- Severe, active other illness
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior radiotherapy to the region of liver or selective internal radiotherapy
- Prior invasive malignancy
- Main portal vein or inferior vena cava (IVC) thrombosis or involvement
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Hong Kong
- Queen Mary HospitalHong Kong, Hong KongContact: Albert ChanTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Stereotactic Body Radiation Therapy followed by ImmunotherapyOther group
The intervention will be done with Stereotactic Body Radiation Therapy and followed by Immunotherapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study
- Plain-language title
- Radiation and immunotherapy to shrink liver cancer that cannot yet be operated onGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07305428, who can take part
- Record updated
- 28 September 2026