SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Radiation: SBRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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); 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT<br>SBRT will be used as the primary bridging therapy for HCC patients on waitlist | Radiation: SBRT<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From time of SBRT to 3 months afterwards | 
| Rate of transplant complication | Perioperative complication will be assessed according to Clavien-Dindo classification | From time of transplant to 1 months afterwards | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From time of enrolment to up to 2 years |