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Clinical trialNCT04777851TerminatedPhase 3Interventional

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

SponsorTranslational Research in OncologyEnrollment45Carcinoma, Hepatocellular
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

REPLACE is a phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of regorafenib and pembrolizumab (Rego-Pembro) versus transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) for the first-line treatment of hepatocellular carcinoma (HCC or liver cancer). Approximately 496 patients in around 80 clinical sites worldwide will be randomized to receive either: * Investigational arm: Regorafenib in combination with pembrolizumab * Control arm: Transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) In both arms, patients will receive trial treatment until progressive disease, unacceptable toxicity, deterioration of patient's condition that warrants permanent trial treatment discontinuation or other treatment discontinuation criteria is met. After trial treatment discontinuation, subsequent treatment will be administered according to the Investigator's clinical judgment.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

26 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Belgium
  • Ucl Saint Luc - Uc Louvain

    Brussels, Belgium

  • Antwerp University Hospital

    Edegem, Belgium

France
  • Chu Amiens-Picardie

    Amiens, France

  • Hôpital Beaujon - Aphp

    Clichy, France

  • Hôpital Henri Mondor

    Créteil, France

Georgia
  • Jsc Viani Batumi Referral Hospital

    Batumi, Georgia

  • Israel-Georgian Medical Research Clinic Healthycore

    Tbilisi, Georgia

Germany
  • Universitätsmedizin: Medizinische Klinik Und Poliklinik I

    Mainz, Germany

Hong Kong
  • Humanity and Health Clinical Trial Center

    Hong Kong, Hong Kong

Italy
  • Ospedale Garibaldi Nesima

    Catania, Italy

Romania
  • Institutul Clinic Fundeni

    Bucharest, Romania

  • Regional Institute of Gastroenterology and Hepatology "dr Octavian Fodor"

    Cluj-Napoca, Romania

  • Center of Oncology Euroclinic Victoria Hospital

    Iași, Romania

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

    Belgrade, Serbia

  • Institue of Oncology Vojvodine Sremska Kamenica (oncology Institute of Volvodina)

    Kamenitz, Serbia

South Korea
  • Inje University Haeundae Paik Hospital

    Busan, South Korea

  • Cha Bundang Medical Center

    Seongnam-si, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

Spain
  • Hospital Universitario la Paz

    Madrid, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, Spain

Taiwan
  • National Taiwan University Hospital

    Taipei, Taiwan

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan, Taiwan

Turkey (Türkiye)
  • Gazi University Mf

    Ankara, Turkey (Türkiye)

  • Gülhane Eğitim Ve Araştırma Hastanesi

    Ankara, Turkey (Türkiye)

  • Koc University Hospital

    Istanbul, Turkey (Türkiye)

United States
  • Ucla Santa Monica Hematology Oncology

    Santa Monica, California, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Regorafenib in combination with pembrolizumab
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
11 Oct 2023
Primary completion
26 Feb 2026
Completion
26 Feb 2026
Last update posted
9 Mar 2026
Registered enrollment
45
Registry id
NCT04777851

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.