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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT | Experimental | SBRT will be used as the primary bridging therapy for HCC patients on waitlist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Wong, MBChB | Contact | 22554848 | wongtcl@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Tiffany Wong, MBChB | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34091914 | Derived | 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. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |