HCCNCT06434480
SBRT in HCC With Oligoprogression on First-line Immunotherapy
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with HCC, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
HCC is a huge healthcare burden in Hong Kong and is one of the top 5 cancers in terms of incidence and mortality in Hong Kong. Patients with advanced HCC are treated with immunotherapy-based as first-line treatment as a standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 21 Jun 2024to 1 Mar 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 years old
- ECOG performance 0 to 1
- Confirmed diagnosis of HCC
- Oligoprogression on first-line immunotherapy, as defined as ≤ 5 lesions (intra- and extrahepatic lesions all together; vascular tumor thrombus is counted as one lesion)
- First-line immunotherapy that are allowed in this study include atezolizumab plus bevacizumab, durvalumab plus tremelimumab, durvalumab, nivolumab and ipilimumab, which are approved by the FDA and have been used in Hong Kong.
- Progressed lesion(s) amenable to SBRT:
Show all 27Show fewer
- For intrahepatic progression:
- Number of intrahepatic progression ≤ 5
- Total intrahepatic tumours ≤ 10
- Maximum sum of HCC ≤ 20cm
- Any one HCC ≤ 20cm
- Normal liver volume minus intrahepatic GTV > 700cc
- Mean liver dose ≤ 15Gy
- No measurable common or main branch biliary duct involvement
- No direct tumor invasion into the stomach, duodenum, small bowel or large bowel
- For extrahepatic progression:
- Maximal tumor size ≤ 7cm
- Respective dose constraints of organ at risks as listed on the UK 2022 Consensus on Normal Tissue Dose-Volume Constraints for Oligometastatic, Primary Lung and Hepatocellular Carcinoma Stereotactic Ablative Radiotherapy can be met and ASTRO guideline.
- Prior radiofrequency ablation (RFA) or trans-arterial chemoembolization (TACE) are eligible
- Child-Pugh A liver function
- Life expectancy longer than 12 weeks
- At least one measurable treatment lesion according to RECIST 1.1
- Written informed consent must be obtained prior to any study related procedures
- Adequate haematological function (Hb ≥ 8.5g/dL; Plt ≥ 50x10^9/L; ANC ≥ 1.0x10^9/L; INR ≤ 1.5)
- Adequate hepatic function (albumin ≥ 28g/L; Bilirubin ≤ 2.5xULN; ALT < 5 times upper limit normal)
- Adequate renal function (serum creatinine ≤ 1.5 times the upper limit of normal range; Na ≥ 130mmol/L; K ≥ 3.0mmol/L)
- Able to read, understand and provide written consent
Who cannot join
- History of another malignancy except appropriately-treated BCC of skin or CIN of cervix during the last 5 years
- Previous radiotherapy to the abdomen
- Previous yttrium-90 chemoembolization
- Repetitive history of non-healing wounds or ulcers within 2 months of inclusion
- Pregnant or lactating females at any time during the study
- Active autoimmune disease requiring systemic therapy in the past 2 years
- Diagnosis of immunodeficiency (including HIV)
- Ongoing corticosteroid therapy >10mg prednisone daily
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
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
Landon L CHAN, MBChB, MSc, 3505 1042, landon.chan@cuhk.edu.hk
Natalie KWONG, RN, 3505 1040, nataliekwong019@cuhk.edu.hk
About this study
Official title: Stereotactic Body Radiotherapy (SBRT) in Advanced Hepatocellular Carcinoma With Oligoprogression on First-line Immunotherapy
HCC is a huge healthcare burden in Hong Kong and is one of the top 5 cancers in terms of incidence and mortality in Hong Kong. Patients with advanced HCC are treated with immunotherapy-based as first-line treatment as a standard of care. At the moment, there is limited evidence to guide subsequent treatments after patients progressed on immunotherapy. Oligoprogression is a term used to describe patients who had limited progression (usually less than 3 sites) on systemic therapy, with the rest of the lesions controlled. Previous studies in non-HCCs have shown that addition of locoregional treatment (e.g. radiotherapy) may prolong the use of systemic therapy, resulting in improved survival, but this has been relatively unexplored for HCC. In this prospective, single-arm study, we aim to evaluate the treatment outcome, efficacy and safety of the addition of radiotherapy to oligoprogressive sites for patients who had limited progression on First-line Immunotherapy.
- Conditions
- HCC
- Being tested
- Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- SBRT in HCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
- For intrahepatic progression: 27.5-50Gy in 5 fractions over 2 weeks is generally recommended.
- For extrahepatic progression: delivery of ablative dose will be attempted.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | Suitable patients are consented and enrolled with the following treatment being given.
* Continue of immunotherapy till next progression, intolerability, or death as per standard practice.
* Radiotherapy will start 4 to 6 weeks after consent
* For intrahepatic progression: 27.5-50Gy in 5 fractions over 2 weeks is generally recommended.
* For extrahepatic progression: delivery of ablative dose (i.e. BED10≥100Gy) will be attempted.
* Lower doses to be delivered (for both intrahepatic and extrahepatic lesions) based on nearby OAR dose constraints are allowed. The final dose and fractionation are at the discretion of the treating oncologist.
* Bevacizumab will need to be withhold 4 weeks prior and after radiotherapy. PD-1 or PD-L1 therapy are allowed to be continued as per the latest ESTRO-ESMO consensus guideline.
* Dose constraints to organ at risk (OAR) will take reference from RTOG-1112 and UK 2022 consensus on normal tissue dose-volume constraints and ASTRO 2022 guideline. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) with the addition of SBRT to oligo-progressive sites
Measured: 2 years
Secondary outcomes (5)
Overall survival (OS)
Measured: 2 years
Objective response rates (ORR) of the irradiated lesion(s)
Measured: 2 years
Overall objective response rates (ORR)
Measured: 2 years
Additional treatment related adverse events (TRAE)
Measured: 2 years
Pattern of progression
Four types of progression pattern:
- EHG (extrahepatic growth)
- IHG (intrahepatic growth)
- NEH (new extrahepatic lesion)
- NIH (new intrahepatic growth)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start21 Jun 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Chinese 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
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Landon Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434480
- Sponsor's protocol ID
- HCC078
- Status last verified
- May 2026
- First submitted
- 14 May 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy (SBRT) in Advanced Hepatocellular Carcinoma With Oligoprogression on First-line Immunotherapy
- ClinicalTrials.gov ID
- NCT06434480
- Acronym / sponsor ID
- HCC078
- Conditions
- HCC
- Keywords
- SBRT in HCC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 30 May 2024 (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.
HCC is a huge healthcare burden in Hong Kong and is one of the top 5 cancers in terms of incidence and mortality in Hong Kong. Patients with advanced HCC are treated with immunotherapy-based as first-line treatment as a standard of care. At the moment, there is limited evidence to guide subsequent treatments after patients progressed on immunotherapy. Oligoprogression is a term used to describe patients who had limited progression (usually less than 3 sites) on systemic therapy, with the rest of the lesions controlled. Previous studies in non-HCCs have shown that addition of locoregional treatment (e.g. radiotherapy) may prolong the use of systemic therapy, resulting in improved survival, but this has been relatively unexplored for HCC. In this prospective, single-arm study, we aim to evaluate the treatment outcome, efficacy and safety of the addition of radiotherapy to oligoprogressive sites for patients who had limited progression on First-line Immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT)Suitable patients are consented and enrolled with the following treatment being given. * Continue of immunotherapy till next progression, intolerability, or death as per standard practice. * Radiotherapy will start 4 to 6 weeks after consent * For intrahepatic progression: 27.5-50Gy in 5 fractions over 2 weeks is generally recommended. * For extrahepatic progression: delivery of ablative dose (i.e. BED10≥100Gy) will be attempted. * Lower doses to be delivered (for both intrahepatic and extrahepatic lesions) based on nearby OAR dose constraints are allowed. The final dose and fractionation are at the discretion of the treating oncologist. * Bevacizumab will need to be withhold 4 weeks prior and after radiotherapy. PD-1 or PD-L1 therapy are allowed to be continued as per the latest ESTRO-ESMO consensus guideline. * Dose constraints to organ at risk (OAR) will take reference from RTOG-1112 and UK 2022 consensus on normal tissue dose-volume constraints and ASTRO 2022 guideline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Patients aged ≥ 18 years old
- ECOG performance 0 to 1
- Confirmed diagnosis of HCC
- Oligoprogression on first-line immunotherapy, as defined as ≤ 5 lesions (intra- and extrahepatic lesions all together; vascular tumor thrombus is counted as one lesion)
- Progressed lesion(s) amenable to SBRT:
Key exclusion criteria (8 listed)
- History of another malignancy except appropriately-treated BCC of skin or CIN of cervix during the last 5 years
- Previous radiotherapy to the abdomen
- Previous yttrium-90 chemoembolization
- Repetitive history of non-healing wounds or ulcers within 2 months of inclusion
- Pregnant or lactating females at any time during the study
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 (SBRT)* For intrahepatic progression: 27.5-50Gy in 5 fractions over 2 weeks is generally recommended. * For extrahepatic progression: delivery of ablative dose will be attempted. | Radiation | Radiotherapy |
Primary outcome
Progression-free survival (PFS) with the addition of SBRT to oligo-progressive sites
Time frame: 2 years
5 secondary outcomes
Overall survival (OS)
Time frame: 2 years
Objective response rates (ORR) of the irradiated lesion(s)
Time frame: 2 years
Overall objective response rates (ORR)
Time frame: 2 years
Additional treatment related adverse events (TRAE)
Time frame: 2 years
Pattern of progression
Time frame: 2 years
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 18 May 2026.
- Individual participant dataSharing planned: No
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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 (SBRT) in people with HCC, run by Chinese 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 27 inclusion and 8 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 18 May 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 Landon L CHAN, MBChB, MSc (3505 1042, landon.chan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) with the addition of SBRT to oligo-progressive sites (time frame: 2 years). 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 18 May 2026.