Last reviewed · How we verify
NCT04763408: STELLAR
A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
trial testing Lenvatinib in Carcinoma, Hepatocellular in 335 participants. Completed in 13 December 2023.
13 December 2023
Quick facts
| Lead sponsor | Eisai Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 335 |
| Start date | 9 April 2021 |
| Primary completion | 13 December 2023 |
| Estimated completion | 13 December 2023 |
| Sites | 44 locations across Italy, Russia, Austria, Sweden, United Kingdom, Germany, Australia, Portugal |
Drugs / interventions tested
- Lenvatinib (LENVATINIB) — full drug profile →
- Sorafenib (SORAFENIB) — full drug profile →
Conditions studied
- Carcinoma, Hepatocellular — all drugs for Carcinoma, Hepatocellular →
Sponsor
Eisai Inc. — full company profile →
Who can join
18 and older, any sex, with Carcinoma, Hepatocellular. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events \[SAEs\], grade 3 to 5 adverse events \[AEs\], dose modifications and discontinuations due to AEs) in participants with advanced or unresectable HCC treated with lenvatinib.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Insights in Molecular Therapies for Hepatocellular Carcinoma.
Heumann P, Albert A, Gülow K, Tümen D, et al · · 2024 · cited 5× · PMID 38791911 · DOI 10.3390/cancers16101831 -
An International Phase 4 Study of Lenvatinib and Sorafenib in Real-World Patients with Unresectable Hepatocellular Carcinoma: Final Analysis
Peck-Radosavljevic M, Abdelgafur A, Granito A, Gasbarrini A, et al · · 2026
Verify or expand the search:
- PubMed search for NCT04763408
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lenvatinib
Trials testing the same drug.
- NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting
- NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer · Phase 3 · not yet recruiting
- NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
- NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin · Phase 2 · not yet recruiting
- NCT07493668 — Fostrox Plus Lenvatinib vs Lenvatinib in Advanced Hepatocellular Carcinoma After First-line Immunotherapy · Phase 2 · not yet recruiting
Other recruiting trials for Carcinoma, Hepatocellular
Currently open trials in the same condition.
- NCT07010497 — A Prospective Study to Evaluate the Safety and Efficacy of the Combination Therapy of Irpagratinib, Atezolizumab, and Be · Phase 2 · recruiting
- NCT07227012 — Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatmen · Phase 1, PHASE2 · recruiting
- NCT06742892 — A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to · Phase 2 · recruiting
- NCT06422403 — A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers · Phase 2 · recruiting
- NCT06349980 — A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or W · Phase 2 · recruiting
Other Eisai Inc. trials
Trials by the same sponsor.
- NCT07493265 — A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy · Phase 2 · not yet recruiting
- NCT07308236 — A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants · Phase 1 · recruiting
- NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
- NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P · active not recruiting
- NCT06602258 — A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease · Phase 2 · active not recruiting
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 NCT04763408 (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 Eisai Inc.
- Last refreshed: 18 July 2024
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/NCT04763408.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing