SBRT and Durvalumab for Inoperable/Unresectable Hepatocellular Carcinoma
NCT04913480 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2021-06-04
Summary
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.
Conditions
Interventions
- DRUG
-
Durvalumab 750mg intravenous infusion once every 2 weeks for 26 cycles
- RADIATION
-
Stereotactic body radiation therapy
Stereotactic body radiation therapy of 27.5Gy to 50Gy in 5 fractions to the liver tumors delivered over 5 to 14 days.
Sponsors & Collaborators
-
The University of Hong Kong
lead OTHER
Principal Investigators
-
Victor Ho Fun Lee, MD · 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
- 2020-10-15
- Primary Completion
- 2023-12-31
- Completion
- 2024-12-31
Countries
- Hong Kong
Study Locations
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