SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
SBRT
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
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.
Sites / Locations
- Queen Mary HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SBRT
Arm Description
SBRT will be used as the primary bridging therapy for HCC patients on waitlist
Outcomes
Primary Outcome Measures
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
Rate of transplant complication
Perioperative complication will be assessed according to Clavien-Dindo classification
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03950102
Brief Title
SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist
Official Title
Prospective Study of Stereotactic Body Radiation Therapy as a Bridging Therapy for Hepatocellular Carcinoma Patients on Waiting List for Liver Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SBRT
Arm Type
Experimental
Arm Description
SBRT will be used as the primary bridging therapy for HCC patients on waitlist
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
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
Primary Outcome Measure Information:
Title
Risk of classical radiation induced liver disease (RILD) after SBRT
Description
Defined as elevated liver transaminases >5 times of upper normal limit or worsening of Child's score by >2 within 3 months after SBRT
Time Frame
From time of SBRT to 3 months afterwards
Title
Rate of transplant complication
Description
Perioperative complication will be assessed according to Clavien-Dindo classification
Time Frame
From time of transplant to 1 months afterwards
Secondary Outcome Measure Information:
Title
Rate of dropout from transplant waitlist
Description
All HCC patients on waitlist will be assessed regularly and will be removed from waitlist if HCC stage is beyond UCSF criteria.
Time Frame
From time of enrolment to up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany Wong, MBChB
Phone
22554848
Email
wongtcl@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Wong, MBChB
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Wong, MBChB
Phone
22554848
Email
wongtcl@hku.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34091914
Citation
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.
Results Reference
derived
Learn more about this trial
SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist
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