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.

Study Overview

• Status: Recruiting
• Conditions: Unresectable Hepatocellular Carcinoma; HCC - Hepatocellular Carcinoma
• Intervention / Treatment: Other: Stereotactic Body Radiation Therapy followed by Immunotherapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Albert Chan; Phone Number: +852 2255 6646; Email: hbptrial@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
    • Principal Investigator: Albert Chan
    • Contact: Albert Chan; Phone Number: +852 2255 6646; Email: hbptrial@hku.hk
    • Sub-Investigator: Chi Leung Chiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Stereotactic Body Radiation Therapy followed by Immunotherapy; The intervention will be done with Stereotactic Body Radiation Therapy and followed by Immunotherapy

Other: Stereotactic Body Radiation Therapy followed by Immunotherapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of successive tumour downstaging	show how many patients will be downstaged by receiving surgery	at the time point of receiving surgery

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Biological Therapy; Immunomodulation; Radiosurgery; Immunotherapy
• Other Study ID Numbers: UW19-286

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No