TACE and SBRT Followed by Double Immunotherapy for Downstaging Hepatocellular Carcinoma

Sponsor
The University of Hong Kong
Study ID
NCT04988945
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TACE — PROCEDURE
    Procedure of TACE will be standardized.
  • SBRT — RADIATION
    SBRT screening and planning will be performed by radiation therapists, medical physicists, and oncologists.
  • Durvalumab — DRUG
    1500mg Durvalumab administered IV over 60 minutes on Day 1 of each immunotherapy treatment every 4 weeks until disease progression (PD)
  • Tremelimumab — DRUG
    300mg Tremelimumab administered over 60 minutes on Day 1 of cycle 1.

Study Details

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.

Key Dates

Start date
Dec 1, 2020
Status verified
Sep 2023
Primary completion
Dec 1, 2024
Completion
Dec 1, 2026

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab + Tremelimumab
    1500mg Durvalumab administered IV over 60 minutes on Day 1 of each immunotherapy treatment every 4 weeks until disease progression (PD) and 300mg Tremelimumab administered over 60 minutes on Day 1 of cycle 1.

Primary Outcome Measure

Downstaging for hepatectomy [ Time Frame: From the date of first study treatment to the date of last study treatment, an average of 3 years ]

Central Contacts

Related Studies