SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist

Hepatocellular Carcinoma Clinical Trial

Official title:

Prospective Study of Stereotactic Body Radiation Therapy as a Bridging Therapy for Hepatocellular Carcinoma Patients on Waiting List for Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03950102
• Other study ID #: UW15-191
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2019
• Source: The University of Hong Kong
• Contact: Tiffany Wong, MBChB
• Phone: 22554848
• Email: wongtcl[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• SBRT
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

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Rate of transplant complication	Perioperative complication will be assessed according to Clavien-Dindo classification	From time of transplant to 1 months afterwards
Secondary	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