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TACE and SBRT Followed by Double Immunotherapy for Downstaging Hepatocellular Carcinoma

NCT04988945 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-09-06

No results posted yet for this study

Summary

This study is a prospective phase II, single arm mono-institutional 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 immune checkpoint inhibitors in unresectable 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

Durvalumab

1500mg Durvalumab administered IV over 60 minutes on Day 1 of each immunotherapy treatment every 4 weeks until disease progression (PD)

DRUG

Tremelimumab

300mg Tremelimumab administered over 60 minutes on Day 1 of cycle 1.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Albert CHAN · Department of Surgery, The University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2024-12-01
Completion
2026-12-01

Countries

  • Hong Kong

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04988945 on ClinicalTrials.gov