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NCT01761266 · ClinicalTrials.gov registry record · Phase 3
A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma
A Phase 3 study, sponsored by Eisai Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 954
- Enrollment target
NCT01761266: Completed Phase 3 study, sponsored by Eisai Limited.
NCT01761266 is a Phase 3 study that has completed, run by Eisai Limited. The registered enrollment target is 954 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01761266, a Phase 3 study, has completed, sponsored by Eisai Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 954 participants
- Enrollment target
Study Summary
E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in participants with unresectable Hepatocellular Carcinoma (HCC).
Primary Outcome
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
Interventions
- DRUG Lenvatinib
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 954 participants |
| Start Date | 2013-03-01 |
| Est. Completion | 2021-03-10 |
| Phase | Phase 3 |
What the finished NCT01761266 record still lists
NCT01761266 is an interventional study that assigns participants to a tested intervention. The registered 954 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 2 interventions - of which Lenvatinib is the first listed.
NCT01761266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01761266 about?
NCT01761266 is a clinical study titled "A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma". E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in participants with unresectable Hepatocellular Carcinoma (HCC).
What is the current status of trial NCT01761266?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 954 participants. The study started on 2013-03-01. Estimated completion is 2021-03-10.
What interventions are being tested in trial NCT01761266?
The interventions under investigation include: Lenvatinib (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT01761266?
This trial is sponsored by Eisai Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01761266's enrollment target sits among peer trials
954 333rd of 2000 higher than 1,668 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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