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RecruitingNCT07305428Updated Sep 28, 2026

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

An interventional study of Stereotactic Body Radiation Therapy followed by Immunotherapy in HCC - Hepatocellular Carcinoma and Unresectable Hepatocellular Carcinoma, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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 current 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.

02

Conditions studied

  • HCC - Hepatocellular Carcinoma
  • Unresectable Hepatocellular Carcinoma
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • OtherStereotactic 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.

    Also known as: SBRT and immunotherapy

05

What researchers measure

Primary outcomes

  1. rate of successive tumour downstaging

    show how many patients will be downstaged by receiving surgery

    Time frame: at the time point of receiving surgery

06

Study locations

1 of 1 sites recruiting
  • Queen Mary Hospital
    Hong Kong, Hong Kong
    • Albert Chan · Contact · hbptrial@hku.hk · +852 2255 6646
    • Albert Chan · Principal investigator
    • Chi Leung Chiang · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT07305428
Lead sponsor
The University of Hong Kong
Responsible party
Albert Chi Yan Chan (Clinical Professor, The University of Hong Kong) — Principal investigator
First posted
Dec 26, 2025
Start date
Apr 25, 2019
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Sep 28, 2026

Study contacts

Albert Chan
Contact
hbptrial@hku.hk
+852 2255 6646

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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