Trial · NCT00901901
Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma
NCT00901901, Phase 3, Completed, Bayer; results first posted 2013-09-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma. Trials, record NCT00901901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00901901
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma
- NCT number
- NCT00901901
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 732 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- Sorafenib (Nexavar, BAY43-9006), Erlotinib (Tarceva), Placebo
- First posted
- 2009-05-14
- Last updated
- 2019-05-30
- Other registries' IDs
- eudract:2008-006021-14
- Results first posted
- 2013-09-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization of the first patient until 34 months or date of death of any cause whichever came first | Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. |
| Secondary | Time to Radiological Tumor Progression (TTP) | From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks | TTP was the time from randomization to radiological tumor progression. Participants without radiological tumor progression at the time of analysis were censored at their last date of tumor evaluation. Progressive disease (PD) was defined using Response Evaluation Criteria in Solid Tumors (RECIST version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Appearance of new lesions also constituted PD. |
| Secondary | Disease Control | From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks | Disease control was defined as the number of participants who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST assessed by magnetic resonance imaging (MRI) that was confirmed at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of target and non-target tumors. PR: at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage for PR nor sufficient increase for PD. |
| Secondary | Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index | The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit. | The European quality of life scale (5 dimensions) (EQ-5D) questionnaire was given to the participants at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems'). The 5 health dimensions are summarized into a single score, the EQ-5D index score. The EQ-5D index score has a range of 0 and 1 with 0 representing death and 1 representing perfect health. |
| Secondary | Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS | The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit. | Participants indicated on a scale of 0 (worst) to 100 (best) how good or bad their health state was on that particular day. |
| Other | Duration of Response | From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks | Duration of response - RECIST: number of days from the date that CR or PR is first documented to date that PD is first objectively documented or to death before progression. Note: the relevant date is that of the first documentation, not the confirmation date (if participant progressed or died then censored=no) or to last observation if participant did not progress or die then censored=yes note: this last observation date should be the same as that used for time to progression. |
| Other | Time to Response | From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks | Time to response was the number of days from randomization to the date the CR or PR was documented (with confirmation) (Note: the relevant date is that of the first documentation, not the confirmation date). |
| Other | Tumor Response | From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks | Tumor response was the proportion of participants with the best tumor response (ie, achieving either a confirmed complete response \[CR\] or partial response \[PR\], according to Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From randomization of the first patient until 34 months or date of death of any cause whichever came first | The full analysis set (FAS), which was defined as all randomized participants | Days | MEDIAN |
| SECONDARY | Time to Radiological Tumor Progression (TTP) | From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks | The full analysis set (FAS), which was defined as all randomized participants | Days | MEDIAN |
| SECONDARY | Disease Control | From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks | The full analysis set (FAS), which was defined as all randomized participants | Participants | NUMBER |
| SECONDARY | Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index | The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit. | The full analysis set (FAS), which was defined as all randomized participants | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS | The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit. | The full analysis set (FAS), which was defined as all randomized participants | Scores on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Duration of Response | From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks | The full analysis set (FAS), which was defined as all randomized participants. Duration of response was evaluated in the 14 participants in the sorafenib + placebo group and 24 participants in the sorafenib + erlotinib group who achieved their confirmed best response as CR or PR. | Days | MEDIAN |
| OTHER_PRE_SPECIFIED | Time to Response | From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks | The full analysis set (FAS), which was defined as all randomized participants. Time to response was evaluated in the 14 participants in the sorafenib + placebo group and 24 participants in the sorafenib + erlotinib group who achieved their confirmed best response as CR or PR. | Days | MEDIAN |
| OTHER_PRE_SPECIFIED | Tumor Response | From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks | The full analysis set (FAS), which was defined as all randomized participants | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | 289 | 95% Confidence Interval 250 to 321 | Days | |
| Overall Survival | Sorafenib (Nexavar, BAY43-9006) + Placebo | 259 | 95% Confidence Interval 226 to 322 | Days | |
| Time to Radiological Tumor Progression (TTP) | Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva) | 97 | 95% Confidence Interval 82 to 126 | Days | |
| Time to Radiological Tumor Progression (TTP) | Sorafenib (Nexavar, BAY 43-9006) + Placebo | 122 | 95% Confidence Interval 88 to 136 | Days | |
| Disease Control | Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva) | 159 | Participants | ||
| Disease Control | Sorafenib (Nexavar, BAY 43-9006) + Placebo | 188 | Participants | ||
| Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index | Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva) | cycle1 | 0.777 | 95% Confidence Interval 0.760 to 0.795 | Scores on a scale |
| Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index | Sorafenib (Nexavar, BAY 43-9006) + Placebo | cycle1 | 0.774 | 95% Confidence Interval 0.757 to 0.790 | Scores on a scale |
| Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index | Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva) | cycle2 | 0.753 | 95% Confidence Interval 0.735 to 0.771 | Scores on a scale |
| Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index | Sorafenib (Nexavar, BAY 43-9006) + Placebo | cycle2 | 0.749 | 95% Confidence Interval 0.732 to 0.766 | Scores on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | 362 | |
| Treatment Period | STARTED | Sorafenib (Nexavar, BAY43-9006) + Placebo | 358 | |
| Treatment Period | Participants Received Treatment | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | 362 | |
| Treatment Period | Participants Received Treatment | Sorafenib (Nexavar, BAY43-9006) + Placebo | 355 | |
| Treatment Period | COMPLETED | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | 193 | |
| Treatment Period | COMPLETED | Sorafenib (Nexavar, BAY43-9006) + Placebo | 181 | |
| Treatment Period | NOT COMPLETED | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | 169 | |
| Treatment Period | NOT COMPLETED | Sorafenib (Nexavar, BAY43-9006) + Placebo | 177 | |
| Follow-up Period | STARTED | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | 340 | |
| Follow-up Period | STARTED | Sorafenib (Nexavar, BAY43-9006) + Placebo | 341 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events964
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 | Edema: Limb | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | 83 | 362 | |
| other | Edema: Limb | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + Placebo | 76 | 355 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | 67 | 362 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + Placebo | 53 | 355 | |
| other | INR | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | 19 | 362 | |
| other | INR | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + Placebo | 19 | 355 | |
| other | Leukocytes | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | 16 | 362 | |
| other | Leukocytes | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + Placebo | 21 | 355 | |
| other | Platelets | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | 44 | 362 | |
| other | Platelets | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + Placebo | 51 | 355 |
1 to 10 of 964Source ClinicalTrials.gov
See all 964 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | ||
| Total, all-cause mortality | Sorafenib (Nexavar, BAY43-9006) + Placebo | ||
| Total, other adverse events | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | 353 | 362 |
| Total, other adverse events | Sorafenib (Nexavar, BAY43-9006) + Placebo | 349 | 355 |
| Total, serious adverse events | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | 214 | 362 |
| Total, serious adverse events | Sorafenib (Nexavar, BAY43-9006) + Placebo | 198 | 355 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva) vs Sorafenib (Nexavar, BAY 43-9006) + Placebo: Tumor Response | Trial comparisons |
| Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva) vs Sorafenib (Nexavar, BAY 43-9006) + Placebo: Disease Control | Trial comparisons |
| Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) vs Sorafenib (Nexavar, BAY43-9006) + Placebo: 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/NCT00901901
GET https://conductscience.org/api/trials/v1/NCT00901901/results?page=2