NCT03397654

Study of Pembrolizumab Following TACE in Primary Liver Carcinoma

A Phase Ib Study of Pembrolizumab Following Trans-Arterial Chemoembolization in Primary Liver Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Primary Liver Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab solution
COMBINATION_PRODUCT	Trans-arterial chemoembolization	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

Timeline

• Start date: 2018-01-28
• Primary completion: 2023-02-01
• Completion: 2023-03-23
• First posted: 2018-01-12
• Last updated: 2025-03-06
• Results posted: 2025-02-03

Locations

1 site across 1 country: United Kingdom