SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Radiation: SBRT

• Registration Number: NCT03950102
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2015-07-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-12
• Study First Posted: 2019-05-15
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Risk of classical radiation induced liver disease (RILD) after SBRT	From time of SBRT to 3 months afterwards	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	From time of transplant to 1 months afterwards	Perioperative complication will be assessed according to Clavien-Dindo classification

Secondary Outcome Measures

Name	Time	Method
Rate of dropout from transplant waitlist	From time of enrolment to up to 2 years	All HCC patients on waitlist will be assessed regularly and will be removed from waitlist if HCC stage is beyond UCSF criteria.

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong