Study of Pembrolizumab and Radiation Therapy in Liver Cancer

Official Title

Pembrolizumab and Stereotactic Radiation Therapy Combined in Subjects With Advanced Hepatocellular Carcinoma - A Phase II Study

Summary:

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

Trial Description

Primary Outcome:

• Overall response rate

Secondary Outcome:

• Response rate in non-irradiated tumour lesions
• Progression-free survival rate
• Overall survival rate

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 radiation therapy 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).

View this trial on ClinicalTrials.gov