Sequential TACE and SBRT Followed by ImmunoTherapy for Downstaging HCC for Hepatectomy
NCT03817736 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2024-05-09
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Merck KGaA, Darmstadt, Germany
collaborator INDUSTRY -
The University of Hong Kong
lead OTHER
Principal Investigators
-
Chi Leung Chiang, Chiang · The University of Hong Kong
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-01
- Primary Completion
- 2022-06-14
- Completion
- 2023-07-26
Countries
- Hong Kong
Study Locations
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