Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07305428

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Queen Mary Hospital

Hong Kong, Hong Kong

Actively Recruiting

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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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