SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist

Prospective Study of Stereotactic Body Radiation Therapy as a Bridging Therapy for Hepatocellular Carcinoma Patients on Waiting List for Liver Transplantation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03950102

Enrollment

Registered

2019-05-15

Start date

2015-07-01

Completion date

2019-12-31

Last updated

2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief 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.

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.

Interventions

RADIATIONSBRT

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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Radiological diagnosis of HCC confirmed according to AASLD criteria 2. All patients who are accepted on deceased donor waiting list 3. HCC within UCSF criteria (defined as solitary tumor \<=6.5cm OR up to 3 tumors \<=4.5cm, total sum \<=8cm)

Exclusion criteria

1. age \<18 year old; 2. Child's C cirrhosis; 3. Eastern Cooperative Oncology Group (ECOG) score \>2; 4. presence of extrahepatic metastasis; 5. radiological tumor invasion to portal, hepatic vein or its branches; 6. absolute contraindications to RT (e.g. previous RT to liver); 7. positive pregnancy test; 8. unwilling or unable to adhere to study requirements and procedure; 9. any other condition, in the investigator's judgment, that increases the risk of SBRT or prevents safe trial participation.

Design outcomes

Primary

Measure	Time frame	Description
Risk of classical radiation induced liver disease (RILD) after SBRT	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	From time of transplant to 1 months afterwards	Perioperative complication will be assessed according to Clavien-Dindo classification

Secondary

Measure	Time frame	Description
Rate of dropout from transplant waitlist	From time of enrolment to up to 2 years	All HCC patients on waitlist will be assessed regularly and will be removed from waitlist if HCC stage is beyond UCSF criteria.

Countries

Hong Kong

Contacts

Primary ContactTiffany Wong, MBChB

wongtcl@hku.hk22554848

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026