Spots Global Cancer Trial Database for Study of Pembrolizumab and Radiotherapy in Liver Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Study of Pembrolizumab and Radiotherapy in Liver Cancer

Official Title: Pembrolizumab and Stereotactic Radiotherapy Combined in Subjects With Advanced Hepatocellular Carcinoma - A Phase II Study

Study ID: NCT03316872

Conditions

Hepatocellular Carcinoma

Interventions

Pembrolizumab

Stereotactic Body Radiotherapy (SBRT)

Study Description

Brief Summary: 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.

Detailed 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 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).