HCC - Hepatocellular CarcinomaNCT07305428
Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study
A study testing Stereotactic Body Radiation Therapy followed by Immunotherapy in people with HCC - Hepatocellular Carcinoma and Unresectable Hepatocellular Carcinoma, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma
- What is being tested?
- Stereotactic Body Radiation Therapy followed by Immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Apr 2019to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Albert Chan, +852 2255 6646, hbptrial@hku.hk
Albert Chan
About this 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 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.
- Being tested
- Stereotactic Body Radiation Therapy followed by Immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy followed by ImmunotherapyOther
Also called SBRT and 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.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy followed by Immunotherapy | Other | The intervention will be done with Stereotactic Body Radiation Therapy and followed by Immunotherapy Receives: Other: Stereotactic Body Radiation Therapy followed by Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of successive tumour downstaging
show how many patients will be downstaged by receiving surgery
Measured: at the time point of receiving surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start25 Apr 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Chi Yan Chan, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305428
- Sponsor's protocol ID
- UW19-286
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study
- ClinicalTrials.gov ID
- NCT07305428
- Acronym / sponsor ID
- UW19-286
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy followed by Immunotherapy | Other | Other: Stereotactic Body Radiation Therapy followed by ImmunotherapyThe intervention will be done with Stereotactic Body Radiation Therapy and followed by Immunotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation Therapy followed by ImmunotherapyAlso: SBRT and immunotherapyStereotactic 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 | Stereotactic Body Radiation Therapy followed by Immunotherapy |
Primary outcome
rate of successive tumour downstaging
Time frame: at the time point of receiving surgery
show how many patients will be downstaged by receiving surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy followed by Immunotherapy in people with HCC - Hepatocellular Carcinoma and Unresectable Hepatocellular Carcinoma, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albert Chan (+852 2255 6646, hbptrial@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of successive tumour downstaging (time frame: at the time point of receiving surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.