SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist

The University of Hong Kong (HKU)

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Radiation: SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT03950102

UW15-191

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

SBRT

Experimental group

Description:

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

Treatment:

Radiation: SBRT