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NCT03289273
Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)
trial testing Regorafenib (Stivarga, BAY73-4506) in Liver Neoplasms in 1,010 participants. Completed in 21 June 2022.
31 January 2022
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,010 |
| Start date | 13 September 2017 |
| Primary completion | 31 January 2022 |
| Estimated completion | 21 June 2022 |
| Sites | 37 locations across Italy, Japan, Taiwan, South Korea, Denmark, Netherlands, Russia, Turkey (Türkiye) |
Drugs / interventions tested
- Regorafenib (Stivarga, BAY73-4506) — full drug profile →
Conditions studied
- Liver Neoplasms — all drugs for Liver Neoplasms →
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):
-
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 -
Systemic Treatment Options in Hepatocellular Carcinoma.
Rimassa L, Pressiani T, Merle P. · · 2019 · cited 96× · PMID 31799201 · DOI 10.1159/000499765 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03289273
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06029010 — An Observational Study to Learn More About the Long-Term Responses to Treatment With Regorafenib in Patients With Metast · completed
- NCT04696055 — Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With · Phase 2 · completed
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Currently open trials in the same condition.
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Other Bayer trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03289273 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 13 June 2023
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