NCT03817736

Sequential TACE and SBRT Followed by ImmunoTherapy for Downstaging HCC for Hepatectomy

Sequential TransArterial Chemoembolization and Stereotactic RadioTherapy Followed by ImmunoTherapy for Downstaging Hepatocellular Carcinoma for Hepatectomy (START-FIT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective phase II, single arm clinical study conducted in Queen Mary Hospital (Hong Kong) assessing the efficacy and safety of the sequential administration of trans-arterial chemo-embolization (TACE) and stereotactic body radiotherapy (SBRT) with an immune checkpoint inhibitor in hepatocellular carcinoma (HCC) patients.

Detailed description

All the patients must be registered with the Investigator(s) prior to initiation of treatment. The registration desk will confirm all eligibility criteria and obtain essential information (including patient number). TACE should start within 28 days of study registration and its procedure will be standardised. SBRT screening and planning will be performed by radiation therapists, medical physicists, and oncologists.

Conditions

• HCC

Interventions

Type	Name	Description
PROCEDURE	TACE	Procedure of TACE will be standardized.
RADIATION	SBRT	SBRT screening and planning will be performed by radiation therapists, medical physicists, and oncologists.
DRUG	Immune Checkpoint Inhibitor	An immune checkpoint inhibitor may be administered up to 3 days before or after the scheduled day of administration of each cycle due to administrative reasons.

Timeline

• Start date: 2019-03-01
• Primary completion: 2022-06-14
• Completion: 2023-07-26
• First posted: 2019-01-25
• Last updated: 2024-05-09

Locations

1 site across 1 country: Hong Kong