Spots Global Cancer Trial Database for IMMULAB - Immunotherapy With Pembrolizumab in Combination With Local Ablation in Hepatocellular Carcinoma (HCC)

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Trial Identification

Brief Title: IMMULAB - Immunotherapy With Pembrolizumab in Combination With Local Ablation in Hepatocellular Carcinoma (HCC)

Official Title: IMMULAB - A Phase II Trial of Immunotherapy With Pembrolizumab in Combination With Local Ablation for Patients With Early Stage Hepatocellular Carcinoma (HCC)

Study ID: NCT03753659

Conditions

Hepatocellular Carcinoma (HCC)

Interventions

Pembrolizumab

Radio Frequency Ablation (RFA)

Microwave Ablation (MWA)

Brachytherapy

Transarterial Chemoembolisation (TACE)

Study Description

Brief Summary: This is a multicenter, single arm, prospective, open-label phase II trial investigating the clinical activity of peri-interventional treatment with the anti-PD1 antibody pembrolizumab in HCC patients who are candidates for local ablation via either radiofrequency ablation (RFA) or microwave ablation (MWA) or brachytherapy or combination of TACE with RFA, MWA or brachytherapy.

Detailed Description: The multimodal approach of combining peri-interventional administration of an immune checkpoint inhibitor and local ablation via RFA / MWA / brachytherapy or combination of TACE with RFA, MWA or brachytherapy harbors the potential to satisfy the unmet need for an improvement in the outcomes of HCC patients treated with RFA / MWA/ brachytherapy or combination of TACE with RFA, MWA or brachytherapy. Furthermore, early clinical data indicates that the combination of immune checkpoint inhibition with RFA, MWA or brachytherapy displays an acceptable safety profile, resulting in a positive benefit-risk ratio of this trial.