Recruiting

NCT Number: NCT07305428

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

HCC - Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Unresectable Hepatocellular Carcinoma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong

Location status: Recruiting

Location contact

Albert Chan

CONTACT

[email protected]

+852 2255 6646

Albert Chan

PRINCIPAL_INVESTIGATOR

Chi Leung Chiang

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic Body Radiation Therapy followed by Immunotherapy

Other

Stereotactic Body Radiation Therapy is a type of external radiation therapy that uses special equipment to position the patient and precisely deliver radiation to a tumor.

Drugs for immunotherapy will be suggested and decided by doctors from Department of Clinical Oncology. The therapy will last for 2 years unless it is no longer helping the disease, or unacceptable toxicity, or until the disease is amendable to surgery.

Other names: SBRT and immunotherapy

Primary outcomes

rate of successive tumour downstaging

Time frame: at the time point of receiving surgery

show how many patients will be downstaged by receiving surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Albert Chan

CONTACT

[email protected]

+852 2255 6646

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2027
Study completion: 2030
First posted: Dec 26, 2025
Registry last updated: Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting