Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study

Official record

Identifier

NCT07305428

Recruiting locations

country

Hong Kong

Interventions studied

Stereotactic Body Radiation Therapy followed by Immunotherapy

Lead sponsor

The University of Hong Kong

Target enrolment

30 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Recruiting

First posted

Dec 26, 2025

Last updated on the registry

Sep 28, 2026

Age

18 Years – 80 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* 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

Exclusion Criteria:

* Prior invasive malignancy
* Prior radiotherapy to the region of liver or selective internal radiotherapy
* Severe, active co-morbidity
* Presence of extra-hepatic metastases (M1)
* Main portal vein or inferior vena cava (IVC) thrombosis or involvement
* 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

Indexed under

Liver Cancer