SBRT and Durvalumab for Inoperable/Unresectable Hepatocellular Carcinoma

Sponsor
The University of Hong Kong
Study ID
NCT04913480
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab 750mg intravenous infusion once every 2 weeks for 26 cycles
  • Stereotactic body radiation therapy — RADIATION
    Stereotactic body radiation therapy of 27.5Gy to 50Gy in 5 fractions to the liver tumors delivered over 5 to 14 days.

Study Details

The investigators propose a phase II single-arm study on using stereotactic body radiation therapy in combination with durvalumab for inoperable/unresectable hepatocellular carcinoma. In addition, the investigators will also measure the change in number and intensity of PD-L1-positive circulating tumor cells before and after stereotactic body radiation therapy and durvalumab and evaluate their correlation with treatment response.

Key Dates

Start date
Oct 15, 2020
Status verified
May 2021
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: Durvalumab and stereotactic body radiation therapy
    1. Durvalumab 750mg intravenous infusion once every 2 weeks for 26 cycles, starting 1 week before commencement of stereotactic body radiation therapy 2. Stereotactic body radiation therapy of 27.5Gy to 50Gy in 5 fractions to the liver tumors delivered over 5 to 14 days

Primary Outcome Measure

Progression-free survival at 1 year [ Time Frame: 12 months ]

Central Contacts

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