CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
Immune Checkpoint Inhibitor +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03817736
NCT03817736Phase 2Completed
CompareCT.gov

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

The University of Hong Kong·interventional·Posted Jan 25, 2019·Updated May 9, 2024

In Brief

A Phase 2 clinical trial evaluating TACE, SBRT, and 1 other intervention for HCC. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHCC
CountriesHong Kong
CollaboratorsMerck KGaA, Darmstadt, Germany

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 25, 2019
Enrollment StartMar 1, 2019
Primary CompletionJun 14, 2022
Study CompletionJul 26, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.4 years ago

Interventions

TACEprocedure

Procedure of TACE will be standardized.

SBRTradiation

SBRT screening and planning will be performed by radiation therapists, medical physicists, and oncologists.

Immune Checkpoint Inhibitordrug

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.