Study of Pembrolizumab and Radiotherapy in Liver Cancer

Sponsor
University Health Network, Toronto
Study ID
NCT03316872
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab is a humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
  • Stereotactic Body Radiotherapy (SBRT) — RADIATION
    SBRT involves delivery of high doses of radiation therapy in smaller fractions

Study Details

This is a phase 2 study whose purpose is to assess the efficacy of the combination of pembrolizumab and stereotactic body radiotherapy (SBRT) in patients with advanced hepatocellular carcinoma (HCC) who have experienced disease progression after treatment with sorafenib.

Key Dates

Start date
Feb 15, 2018
Status verified
Jul 2025
Primary completion
Feb 15, 2024
Completion
Feb 15, 2024

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab and Stereotactic Body Radiotherapy (SBRT)
    Pembrolizumab, intravenously, at a dose of 200 mg, once every 3 weeks SBRT starting Day 2 of Cycle 1 of pembrolizumab treatment, given in 5 fractions over 10-15 days.

Primary Outcome Measure

Overall Response Rate [ Time Frame: 3 years ]

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