Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

496

Participants

Timeline

Start Date

October 11, 2023

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2026

Conditions
Carcinoma, Hepatocellular
Interventions
DRUG

Regorafenib in combination with pembrolizumab

Randomized patients will receive regorafenib at a dose of 90 mg per day by mouth on days 1 to 21 of a 28-day cycle, in combination with pembrolizumab 400 mg using a 30-minute intravenous infusion, on day 1 (D1) of a 6-week cycle.

PROCEDURE

Loco-regional therapy

"Patients will be treated with TACE or TARE on-demand according to site's standard of practice."

Trial Locations (26)

333

Chang Gung Memorial Hospital - Linkou, Taoyuan District

1200

UCL SAINT LUC - UC Louvain, Brussels

2650

Antwerp University Hospital, Edegem

6010

JSC VIANI Batumi Referral Hospital, Batumi

Gülhane Eğitim ve Araştırma Hastanesi, Ankara

6560

Gazi University MF, Ankara

10041

National Taiwan University Hospital, Taipei

21204

Institue of Oncology Vojvodine Sremska Kamenica (Oncology Institute of Volvodina), Kamenitz

22328

Institutul Clinic Fundeni, Bucharest

28046

Hospital Universitario La Paz, Madrid

34010

Koc University Hospital, Istanbul

50009

Hospital Universitario Miguel Servet, Zaragoza

80054

CHU Amiens-Picardie, Amiens

90404

UCLA Santa Monica Hematology Oncology, Santa Monica

92110

Hôpital Beaujon - APHP, Clichy

94010

Hôpital Henri Mondor, Créteil

95122

Ospedale Garibaldi Nesima, Catania

400394

"Regional Institute of Gastroenterology and Hepatology Dr Octavian Fodor", Cluj-Napoca

700106

Center of Oncology Euroclinic Victoria Hospital, Iași

999077

Humanity and Health Clinical Trial Center, Hong Kong

0112

Israel-Georgian Medical Research Clinic Healthycore, Tbilisi

D-55131

Universitätsmedizin: Medizinische Klinik und Poliklinik I, Mainz

Unknown

Clinic for Digestive Surgery, University Clinical Center of Serbia, Belgrade

Inje University Haeundae Paik Hospital, Busan

Cha Bundang Medical Center, Seongnam-si

Severance Hospital, Yonsei University Health System, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Translational Research in Oncology

OTHER

NCT04777851 - Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7 | Biotech Hunter | Biotech Hunter