Hepatocellular CarcinomaNCT03950102
SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist
A study testing SBRT in people with Hepatocellular Carcinoma, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a single center, prospective study to assess the efficacy and safety of using stereotactic body radiation therapy (SBRT) as bridging treatment for hepatocellular carcinoma (HCC) patients on transplant waitlist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2015to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Radiological diagnosis of HCC confirmed according to AASLD criteria
- All patients who are accepted on deceased donor waiting list
- HCC within UCSF criteria (defined as solitary tumor <=6.5cm OR up to 3 tumors <=4.5cm, total sum <=8cm)
Who cannot join
- age <18 year old;
- Child's C cirrhosis;
- Eastern Cooperative Oncology Group (ECOG) score >2;
- presence of extrahepatic metastasis;
- radiological tumor invasion to portal, hepatic vein or its branches;
- absolute contraindications to RT (e.g. previous RT to liver);
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- positive pregnancy test;
- unwilling or unable to adhere to study requirements and procedure;
- any other condition, in the investigator's judgment, that increases the risk of SBRT or prevents safe trial participation.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Tiffany Wong, MBChB, 22554848, wongtcl@hku.hk
About this study
Official title: Prospective Study of Stereotactic Body Radiation Therapy as a Bridging Therapy for Hepatocellular Carcinoma Patients on Waiting List for Liver Transplantation
This is a single center, prospective study to assess the efficacy and safety of using stereotactic body radiation therapy (SBRT) as bridging treatment for hepatocellular carcinoma (HCC) patients on transplant waitlist.
Read the detailed description
The study population includes patients 18 years of age or older with HCC, who are accepted on waiting list for deceased donor liver transplantation (DDLT).
Patient will be assessed in a multidisciplinary committee and they will receive SBRT unless otherwise contraindicated. Patients will undergo SBRT under standard protocol.
Patients with HCC beyond University of California, San Francisco criteria (UCSF) will be removed from waitlist.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- SBRT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Radiation dose of 27.5-50Gy in 5 fractions over 5-14 days with a radical dose as high as achievable based on mean liver dose (MLD), while fulfilling the dose constraints of OARs
| Study group | Role | What they receive |
|---|---|---|
| SBRT | Experimental | SBRT will be used as the primary bridging therapy for HCC patients on waitlist Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of classical radiation induced liver disease (RILD) after SBRT
Defined as elevated liver transaminases >5 times of upper normal limit or worsening of Child's score by >2 within 3 months after SBRT
Measured: From time of SBRT to 3 months afterwards
Rate of transplant complication
Perioperative complication will be assessed according to Clavien-Dindo classification
Measured: From time of transplant to 1 months afterwards
Secondary outcomes (1)
Rate of dropout from transplant waitlist
All HCC patients on waitlist will be assessed regularly and will be removed from waitlist if HCC stage is beyond UCSF criteria.
Measured: From time of enrolment to up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jul 2015
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tiffany Cho-Lam Wong, The University of Hong Kong
- Investigators
- Tiffany Wong, MBChB, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950102
- Sponsor's protocol ID
- UW15-191
- Status last verified
- May 2019
- First submitted
- 2 May 2019
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong TC, Lee VH, Law AL, Pang HH, Lam KO, Lau V, Cui TY, Fong AS, Lee SW, Wong EC, Dai JW, Chan AC, Cheung TT, Fung JY, Yeung RM, Luk MY, Leung TW, Lo CM. Prospective Study of Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma on Waitlist for Liver Transplant. Hepatology. 2021 Nov;74(5):2580-2594. doi: 10.1002/hep.31992. Epub 2021 Sep 30.
PubMed 34091914
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Stereotactic Body Radiation Therapy as a Bridging Therapy for Hepatocellular Carcinoma Patients on Waiting List for Liver Transplantation
- ClinicalTrials.gov ID
- NCT03950102
- Acronym / sponsor ID
- UW15-191
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 15 May 2019 (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.
This is a single center, prospective study to assess the efficacy and safety of using stereotactic body radiation therapy (SBRT) as bridging treatment for hepatocellular carcinoma (HCC) patients on transplant waitlist.
Detailed description
The study population includes patients 18 years of age or older with HCC, who are accepted on waiting list for deceased donor liver transplantation (DDLT).
Patient will be assessed in a multidisciplinary committee and they will receive SBRT unless otherwise contraindicated. Patients will undergo SBRT under standard protocol.
Patients with HCC beyond University of California, San Francisco criteria (UCSF) will be removed from waitlist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT | Experimental | Radiation: SBRTSBRT will be used as the primary bridging therapy for HCC patients on waitlist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Radiological diagnosis of HCC confirmed according to AASLD criteria
- All patients who are accepted on deceased donor waiting list
- HCC within UCSF criteria (defined as solitary tumor <=6.5cm OR up to 3 tumors <=4.5cm, total sum <=8cm)
Key exclusion criteria (9 listed)
- age <18 year old;
- Child's C cirrhosis;
- Eastern Cooperative Oncology Group (ECOG) score >2;
- presence of extrahepatic metastasis;
- radiological tumor invasion to portal, hepatic vein or its branches;
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 |
|---|---|---|
| SBRTRadiation dose of 27.5-50Gy in 5 fractions over 5-14 days with a radical dose as high as achievable based on mean liver dose (MLD), while fulfilling the dose constraints of OARs | Radiation | SBRT |
Primary outcome
Risk of classical radiation induced liver disease (RILD) after SBRT
Time frame: From time of SBRT to 3 months afterwards
Defined as elevated liver transaminases >5 times of upper normal limit or worsening of Child's score by >2 within 3 months after SBRT
Rate of transplant complication
Time frame: From time of transplant to 1 months afterwards
Perioperative complication will be assessed according to Clavien-Dindo classification
1 secondary outcome
Rate of dropout from transplant waitlist
Time frame: From time of enrolment to up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Derived from this study: PubMed 34091914Wong TC, Lee VH, Law AL, Pang HH, Lam KO, Lau V, Cui TY, Fong AS, Lee SW, Wong EC, Dai JW, Chan AC, Cheung TT, Fung JY, Yeung RM, Luk MY, Leung TW, Lo CM. Prospective Study of Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma on Waitlist for Liver Transplant. Hepatology. 2021 Nov;74(5):2580-2594. doi: 10.1002/hep.31992. Epub 2021 Sep 30.
- 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. This study is not recruiting at the moment.
Tiffany Wong, MBChB principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Wong, MBChB (22554848, wongtcl@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of classical radiation induced liver disease (RILD) after SBRT (time frame: From time of SBRT to 3 months afterwards). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03950102, which also lists 1 linked publication.
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 May 2019.