Study of Pembrolizumab and Radiotherapy in Liver Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hepatocellular Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Pembrolizumab will be administered intravenously as a 30-minute infusion at a dose of 200 mg every 21 days, until disease progression or intolerable toxicity. Stereotactic radiotherapy will commence on day 2 of the first cycle of pembrolizumab, and will be delivered in 5 fractions over 8-15 days in ...
Pembrolizumab will be administered intravenously as a 30-minute infusion at a dose of 200 mg every 21 days, until disease progression or intolerable toxicity. Stereotactic radiotherapy will commence on day 2 of the first cycle of pembrolizumab, and will be delivered in 5 fractions over 8-15 days in accordance with institutional protocol. Subjects will be re-evaluated for response every 12 weeks. In addition to a baseline scan, confirmatory scans should also be obtained 4-8 weeks following initial documentation of objective response. Response and progression will be evaluated in this study using both RECIST 1.1and (iRECIST) guideline (Seymor 2017).
Tracking Information
- NCT #
- NCT03316872
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jennifer J. Knox, M.D. Princess Margaret Cancer Centre
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