Open label, single arm, multi-centre study of pembrolizumab following trans-arterial chemoembolization (TACE). Twenty-six to 32 evaluable participants with primary liver cancer (hepatocellular cancer; HCC) will be assessed. The primary objective is to determine the safety and tolerability of pembrolizumab following TACE. The secondary objective is to evaluate the efficacy of pembrolizumab following TACE by improving progression-free survival rates as measured by modified response evaluation criteria in solid tumours (mRECIST) criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Pembrolizumab solution
Doxorubicin injected through the hepatic blood supply directly to the cancer-affected part of the liver, then gelatin sponge particles injected to block the blood vessels supplying the tumour
Imperial College Healthcare NHS Trust
London, United Kingdom
Incidence of Treatment-emergent Adverse Events (Safety and Tolerability)
The safety and tolerability of pembrolizumab will be assessed by recording the incidence of adverse events (AEs) using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE v4).
Time frame: from the first pembrolizumab administration to up to 130 days after the last dose, 1.5 years
Progression-free Survival Rate (PFS; Efficacy) at 12 Weeks
PFS was defined by the time from last TACE to the first occurrence of documented disease progression based on RECIST v1.1 criteria or death from any cause, whichever occurred first, and it was calculated using Kaplan-Meier.
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.