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

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.

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Radiation: SBRT

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
    • Contact: Tiffany Wong, MBChB; Phone Number: 22554848; Email: wongtcl@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBRT; SBRT will be used as the primary bridging therapy for HCC patients on waitlist	Radiation: SBRT; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Tiffany Wong, MBChB, The University of Hong Kong

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 12, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: UW15-191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No