Last reviewed · How we verify

NCT03289273

Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)

Completed Last updated 13 June 2023
What this trial tests

trial testing Regorafenib (Stivarga, BAY73-4506) in Liver Neoplasms in 1,010 participants. Completed in 21 June 2022.

Timeline
13 September 2017
Primary endpoint
31 January 2022
21 June 2022

Quick facts

Lead sponsorBayer
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,010
Start date13 September 2017
Primary completion31 January 2022
Estimated completion21 June 2022
Sites37 locations across Italy, Japan, Taiwan, South Korea, Denmark, Netherlands, Russia, Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

Eligibility, any sex, with Liver Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Experience with regorafenib in the treatment of hepatocellular carcinoma.
    Granito A, Forgione A, Marinelli S, Renzulli M, et al · · 2021 · cited 97× · PMID 34104211 · DOI 10.1177/17562848211016959
  2. Systemic Treatment Options in Hepatocellular Carcinoma.
    Rimassa L, Pressiani T, Merle P. · · 2019 · cited 96× · PMID 31799201 · DOI 10.1159/000499765
  3. Systemic Treatment for Advanced Hepatocellular Carcinoma.
    Bouattour M, Mehta N, He AR, Cohen EI, et al · · 2019 · cited 84× · PMID 31768344 · DOI 10.1159/000496439
  4. Regorafenib Combined with Other Systemic Therapies: Exploring Promising Therapeutic Combinations in HCC.
    Granito A, Marinelli S, Forgione A, Renzulli M, et al · · 2021 · cited 25× · PMID 34079777 · DOI 10.2147/jhc.s251729
  5. Genetic Biomarkers For Hepatocellular Carcinoma In The Era Of Precision Medicine.
    Duan J, Wu Y, Liu J, Zhang J, et al · · 2019 · cited 23× · PMID 31696097 · DOI 10.2147/jhc.s224849
  6. Beyond atezolizumab plus bevacizumab in patients with advanced hepatocellular carcinoma: overall efficacy and safety of tyrosine kinase inhibitors in a real-world setting.
    Falette-Puisieux M, Nault JC, Bouattour M, Lequoy M, et al · · 2023 · cited 15× · PMID 37547443 · DOI 10.1177/17588359231189425
  7. Regorafenib for Hepatocellular Carcinoma in Real-World Practice (REFINE): A Prospective, Observational Study.
    Kim YJ, Merle P, Finn RS, Kudo M, et al · · 2025 · cited 4× · PMID 40831889 · DOI 10.1159/000542285
  8. Tolerability and Effectiveness of Regorafenib Treatment in Patients with Unresectable Hepatocellular Carcinoma: Real-World Data from the United States.
    Finn RS, Iyer R, Kalman RS, Parikh ND, et al · · 2025 · cited 2× · PMID 39935697 · DOI 10.2147/jhc.s459983

Verify or expand the search:

Other trials of Regorafenib (Stivarga, BAY73-4506)

Trials testing the same drug.

Other recruiting trials for Liver Neoplasms

Currently open trials in the same condition.

Other Bayer trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03289273.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing