SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist

NCT03950102 | Unknown

• 1 other identifier: UW15-191
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Rate of dropout from transplant waitlist

  From time of enrolment to up to 2 years

Study Arms (1)

SBRT

EXPERIMENTAL

SBRT will be used as the primary bridging therapy for HCC patients on waitlist

Radiation: SBRT

Interventions

SBRT RADIATION

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

SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• 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.

  PMID: 34091914 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Tiffany Wong, MBChB

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Wong, MBChB

CONTACT

22554848; wongtcl@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 15, 2019
• Study Start: July 1, 2015
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)