NCT07305428

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

Recruiting now NA Last updated 26 December 2025

What this trial tests

NA trial testing Stereotactic Body Radiation Therapy followed by Immunotherapy in HCC - Hepatocellular Carcinoma in 30 participants. Currently enrolling.

Timeline

25 April 2019

Primary endpoint
31 December 2027

31 December 2030

Quick facts

Lead sponsor	The University of Hong Kong
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	25 April 2019
Primary completion	31 December 2027
Estimated completion	31 December 2030
Sites	1 location across Hong Kong

Drugs / interventions tested

• Stereotactic Body Radiation Therapy followed by Immunotherapy

Conditions studied

• HCC - Hepatocellular Carcinoma — all drugs for HCC - Hepatocellular Carcinoma →
• Unresectable Hepatocellular Carcinoma — all drugs for Unresectable Hepatocellular Carcinoma →

Sponsor

The University of Hong Kong

Who can join

Adults 18 to 80, any sex, with HCC - Hepatocellular Carcinoma or Unresectable Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Combining External Beam Radiotherapy and Immunotherapy for the Treatment of Hepatocellular Carcinoma.
   Le C, Abraham AG, Tankel K, Usmani N, et al · · 2026 · PMID 42041745 · DOI 10.3390/curroncol33040226