Trial · NCT01761266
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
NCT01761266, Phase 3, Completed, Eisai Limited; results first posted 2018-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT01761266. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01761266
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT01761266
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 954 participants, actual
- Lead sponsor
- Eisai Limited
- Conditions
- Hepatocellular Carcinoma (HCC)
- Interventions
- Lenvatinib, Sorafenib
- First posted
- 2013-01-04
- Last updated
- 2022-04-05
- Other registries' IDs
- eudract:2012-002992-33
- Results first posted
- 2018-09-25
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From date of randomization until date of death from any cause (approximately up to 3.8 years) | 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. |
| Secondary | Progression Free Survival (PFS) | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years) | PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first. Disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date. |
| Secondary | Time to Progression (TTP) | The time from the date of randomization to the date of first documentation of disease progression (approximately up to 3.8 years) | TTP was defined as the time from the date of randomization to the date of first documentation of disease progression based on mRECIST. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date. |
| Secondary | Objective Response Rate (ORR) | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years) | ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on mRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date. |
| Secondary | Time to Clinically Meaningful Worsening of Health Related Quality of Life (HRQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Baseline up to Off-Treatment Visit (approximately up to 3.8 years) | The EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social) and 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, insomnia, constipation, diarrhea and financial difficulties) and a single global health and QOL status score. Most questions used a 4-point scale (1=Not at all to 4=Very much); 2 questions used a 7-point scale (1= Very poor to 7=Excellent). All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date. |
| Secondary | Time to Clinically Meaningful Worsening of HRQoL Assessed Using - EORTC QLQ- Hepatocellular Carcinoma Domain (HCC 18) | Baseline up to Off-Treatment Visit (approximately up to 3.8 years) | The EORTC QLQ-HCC-18 was an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30. EORTC QLQ-HCC 18 questionnaire included 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. Each individual item ranges from 1 to 4, where 1 = "not at all" and 4 = "very much." All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represented a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represented a high QoL, but a high score for a symptom scale/item represented a high level of symptomatology/problem. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date. |
| Secondary | Time to Clinically Meaningful Worsening of HRQoL Assessed Using EuroQol Five Dimension Health Questionnaire (EQ-5D-3L) | Baseline up to Off-Treatment Visit (approximately up to 3.8 years) | The EuroQol five dimension health questionnaire (EQ-5D-3L) assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 3-15 with "3" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. EQ-5D-3L also included an EQ visual analogue scale (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score was weighted with a range of -0.594 (worst) to 1.0 (best). EQ-5D-3L also included an EQ health utilities index (HUI) where 1.00 indicated perfect health while a score of 0.00 indicated death. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date. |
| Secondary | Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib | Cycle 1 Day 1, Cycle 2 Day 1: pre-dose, 0.5-4 and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 2-12 hours post-dose (cycle length= 28 days) | AUC was assessed on Cycle 1 Day 1, Cycle 2 Day 1 and Cycle 1 Day 15. Summarized data for all time points was reported. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date. |
| Other | Disease Control Rate (DCR) | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years) | DCR was defined as the percentage of participants with a best overall response of CR or PR, or stable disease (SD). Best overall response of SD must have been \>=7 weeks after randomization. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. SD was when a case does not qualify for either PR or PD and was new non-target lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. As planned, data for this pre-specified endpoint was collected and analyzed up to the primary completion date. |
| Other | Clinical Benefit Rate (CBR) | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years) | CBR was defined as the percentage of participants with a best overall response of CR or PR or durable SD (duration of SD \>=23 weeks after randomization). For participants whose best overall response (BOR) was SD, the duration of SD was defined as the time from the date of randomization to the first documented PD or death, whichever occurred first. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. SD was when a case does not qualify for either PR or PD. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. As planned, data for this pre-specified endpoint was collected and analyzed up to the primary completion date. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From date of randomization until date of death from any cause (approximately up to 3.8 years) | The FAS included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years) | The FAS included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Time to Progression (TTP) | The time from the date of randomization to the date of first documentation of disease progression (approximately up to 3.8 years) | The FAS included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years) | The FAS included all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Time to Clinically Meaningful Worsening of Health Related Quality of Life (HRQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Baseline up to Off-Treatment Visit (approximately up to 3.8 years) | The FAS included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Time to Clinically Meaningful Worsening of HRQoL Assessed Using - EORTC QLQ- Hepatocellular Carcinoma Domain (HCC 18) | Baseline up to Off-Treatment Visit (approximately up to 3.8 years) | The FAS included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Time to Clinically Meaningful Worsening of HRQoL Assessed Using EuroQol Five Dimension Health Questionnaire (EQ-5D-3L) | Baseline up to Off-Treatment Visit (approximately up to 3.8 years) | The FAS included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib | Cycle 1 Day 1, Cycle 2 Day 1: pre-dose, 0.5-4 and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 2-12 hours post-dose (cycle length= 28 days) | The pharmacokinetic (PK) analysis set included all participants who had received at least 1 dose of lenvatinib and had at least 1 quantifiable lenvatinib concentration. | nanogram*hour per milliliter (ng*h/mL) | MEAN |
| OTHER_PRE_SPECIFIED | Disease Control Rate (DCR) | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years) | The FAS included all participants who were randomized. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Clinical Benefit Rate (CBR) | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years) | The FAS included all participants who were randomized. | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group156
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Lenvatinib | 13.6 | 95% Confidence Interval 12.1 | months | |
| Overall Survival (OS) | Sorafenib | 12.3 | 95% Confidence Interval 10.4 | months | |
| Progression Free Survival (PFS) | Lenvatinib | 7.4 | 95% Confidence Interval 6.9 | months | |
| Progression Free Survival (PFS) | Sorafenib | 3.7 | 95% Confidence Interval 3.6 | months | |
| Time to Progression (TTP) | Lenvatinib | 8.9 | 95% Confidence Interval 7.4 | months | |
| Time to Progression (TTP) | Sorafenib | 3.7 | 95% Confidence Interval 3.6 | months | |
| Objective Response Rate (ORR) | Lenvatinib | 24.1 | 95% Confidence Interval 20.2 | percentage of participants | |
| Objective Response Rate (ORR) | Sorafenib | 9.2 | 95% Confidence Interval 6.6 | percentage of participants | |
Time to Clinically Meaningful Worsening of Health Related Quality of Life (HRQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Lenvatinib | 1.7 | 95% Confidence Interval 1.05 | months | |
Time to Clinically Meaningful Worsening of Health Related Quality of Life (HRQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Sorafenib | 1.8 | 95% Confidence Interval 1.05 | months |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenvatinib | 478 | |
| Overall Study | STARTED | Sorafenib | 476 | |
| Overall Study | Treated | Lenvatinib | 476 | |
| Overall Study | Treated | Sorafenib | 475 | |
| Overall Study | COMPLETED | Lenvatinib | 0 | |
| Overall Study | COMPLETED | Sorafenib | 0 | |
| Overall Study | NOT COMPLETED | Lenvatinib | 478 | |
| Overall Study | NOT COMPLETED | Sorafenib | 476 |
Source ClinicalTrials.gov
Adverse events586
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ascites | Gastrointestinal disorders | Lenvatinib | 63 | 476 | 82 |
| other | Ascites | Gastrointestinal disorders | Sorafenib | 39 | 475 | 54 |
| other | Constipation | Gastrointestinal disorders | Lenvatinib | 76 | 476 | 95 |
| other | Constipation | Gastrointestinal disorders | Sorafenib | 52 | 475 | 62 |
| other | Diarrhoea | Gastrointestinal disorders | Lenvatinib | 186 | 476 | 406 |
| other | Diarrhoea | Gastrointestinal disorders | Sorafenib | 223 | 475 | 448 |
| other | Dyspepsia | Gastrointestinal disorders | Lenvatinib | 31 | 476 | 40 |
| other | Dyspepsia | Gastrointestinal disorders | Sorafenib | 18 | 475 | 20 |
| other | Nausea | Gastrointestinal disorders | Lenvatinib | 90 | 476 | 131 |
| other | Nausea | Gastrointestinal disorders | Sorafenib | 71 | 475 | 94 |
1 to 10 of 586Source ClinicalTrials.gov
See all 586 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenvatinib | 415 | 478 |
| Total, all-cause mortality | Sorafenib | 402 | 476 |
| Total, other adverse events | Lenvatinib | 469 | 476 |
| Total, other adverse events | Sorafenib | 469 | 475 |
| Total, serious adverse events | Lenvatinib | 209 | 476 |
| Total, serious adverse events | Sorafenib | 149 | 475 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lenvatinib vs Sorafenib: deaths from any cause | Trial comparisons |
| Lenvatinib vs Sorafenib: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01761266
GET https://conductscience.org/api/trials/v1/NCT01761266/results?page=2