Trial · NCT00692770
Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)
NCT00692770, Phase 3, Completed, Bayer; results first posted 2014-12-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM). Trials, record NCT00692770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00692770
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)
- NCT number
- NCT00692770
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,114 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- Nexavar (Sorafenib, BAY43-9006), Placebo
- First posted
- 2008-06-06
- Last updated
- 2018-08-08
- Other registries' IDs
- eudract:2008-001087-36
- Results first posted
- 2014-12-01
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrence Free Survival (RFS) by Independent Assessment | From randomization up to 4 years or until disease recurrence whichever came first | Disease recurrence of HCC (intra or extra hepatic) was defined as the appearance of a new intrahepatic lesions fulfilling the American Association for the Study of Liver Diseases (AASLD) criteria of diagnosis of HCC or a new extra-hepatic lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. In addition to investigator assessment, all images were reviewed by an independent panel of radiologists. The calculation of the RFS was based on the independent evaluation of the scans. RFS was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment or death due to any cause whichever occurred first. For subjects who had not recurred or died at the time of analysis, RFS was censored at their last date of evaluable scan before drop-out for any other reason than recurrence or death. |
| Secondary | Time to Recurrence (TTR) by Independent Assessment | From randomization up to 4 years or until disease recurrence whichever came first | TTR was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment. For subjects who had not recurred at the time of analysis, TTR was censored at their last date of evaluable scan before withdrawal for any other reason than recurrence. "NA" in the reported data indicates values could not be estimated due to censored data. |
| Secondary | Overall Survival (OS) | From randomization of the first subject until 4 years later. | OS was defined as the time from randomization to date of death due to any cause. OS for subjects alive at the time of analysis was censored at their last date of contact. "NA" in the reported data indicates values could not be estimated due to censored data. |
| Other | Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score | Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit | The EQ-5D is a generic quality of life preference based on a validated instrument used in cancer and in general population, with 2 parts: Index and Visual Analogue Scale. The EQ-5D Index is a descriptive system of the following health dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Subjects were asked to choose any one of the 3 response levels for each dimension: no problems, some problems, and severe problems. The 5 health dimensions were summarized into a single score, the EQ-5D Index score which ranged from -0.59 to 1 with higher scores representing better health states (0=death, 1= perfect health, and -0.59=a health state worse than death). A change of at least 0.10 to 0.12 points was considered a minimally important difference using Eastern Cooperative Oncology Group Performance Status as the anchor. The results on the Analysis of covariance of timeadjusted Area under curve for the EQ-5D index score were reported. |
| Other | Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score | Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit | The EQ-5D is a generic quality of life preference based on a validated instrument used in cancer and in general population, with 2 parts: Index and Visual Analogue Scale. The EQ-5D VAS is a measure that represents health status as a single value. It is a 20-centimetre vertical graduated visual analogue scale with scores that ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). The respondent rated his/her current health state by drawing a line from the box marked 'your own health state today' to the appropriate point on the EQ-5D VAS. A 3-digit number (including leading zeros) was read off the scale from the point where the respondent's line crossed the scale, which was the EQ-5D VAS score. A change of at least 7 points on the VAS was considered as minimally important. The results on the ANCOVA analysis of time-adjusted AUC for the EQ-5D VAS score were reported. |
| Other | Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- Hepatobiliary Subscale (HEP) Score | Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit | The FACT-HEP is a 45 item, self-administered, multi-dimensional, psychometrically sound questionnaire used extensively in oncology clinical trials. FACT-HEP consisted of five subscales: Physical Well-Being (PWB), Social Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and Hepatobiliary Cancer Subscale (HCS). The PWB, FWB, SWB and EWB were summed to form the FACTGeneral (FACT-G) total score. The FACT-G and HCS scores were summed to form the FACT-HEP total score. FACT-HEP scores ranged from 0 to 180 and the higher scores represented a better quality of life. Subjects responded to each item on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). The minimally important difference (MID) for the FACT-Hep total score was in the range of 8 to 9. The results on the ANCOVA analysis of time-adjusted AUC for the FACT-HEP score were reported. |
| Other | Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- General (G) Total Score | Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit | The PWB, FWB, SWB and EWB were summed to form the FACT-G total score. Subjects responded to each item on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). FACT-G scores ranged from 0 to 108 and the higher scores represented a better quality of life. The MID for the FACT-G total score was in the range of 6 to 7. The results on the ANCOVA analysis of time-adjusted AUC for the FACT-G score were reported. |
| Other | The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - ANG-2 | At Baseline | Biomarker was analyzed at baseline \[i.e., before treatment\] as a dichotomized variable based on median biomarker levels, and dichotomized into "high" and "low" groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only. |
| Other | The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - AFP | At Baseline | Biomarker was analyzed at baseline \[i.e., before treatment\] as a dichotomized variable based on median biomarker levels, and dichotomized into "high" and "low" groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only. |
| Other | The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - MET | At Baseline | Biomarker was analyzed at baseline \[i.e., before treatment\] as a dichotomized variable based on median biomarker levels, and dichotomized into "high" and "low" groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recurrence Free Survival (RFS) by Independent Assessment | From randomization up to 4 years or until disease recurrence whichever came first | Full analysis set (FAS) included participants who were randomized to study treatments. | Days | MEDIAN |
| SECONDARY | Time to Recurrence (TTR) by Independent Assessment | From randomization up to 4 years or until disease recurrence whichever came first | FAS included participants who were randomized to study treatments. | Days | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization of the first subject until 4 years later. | FAS included participants who were randomized to study treatments. | Days | MEDIAN |
| OTHER_PRE_SPECIFIED | Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score | Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit | FAS included participants who were randomized to study treatments. | Unit on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score | Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit | FAS included participants who were randomized to study treatments. | Unit on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- Hepatobiliary Subscale (HEP) Score | Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit | FAS included participants who were randomized to study treatments. | Unit on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- General (G) Total Score | Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit | FAS included participants who were randomized to study treatments. | Unit on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - ANG-2 | At Baseline | Plasma biomarker analysis was done in 858 (77%) of the all enrolled subjects. | Days | MEDIAN |
| OTHER_PRE_SPECIFIED | The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - AFP | At Baseline | Plasma biomarker analysis was done in 858 (77%) of the all enrolled subjects. | Days | MEDIAN |
| OTHER_PRE_SPECIFIED | The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - MET | At Baseline | Plasma biomarker analysis was done in 858 (77%) of the all enrolled subjects. | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recurrence Free Survival (RFS) by Independent Assessment | Sorafenib (Nexavar, BAY43-9006) | 1014 | 95% Confidence Interval 839 to 1339 | Days | |
| Recurrence Free Survival (RFS) by Independent Assessment | Placebo | 1026 | 95% Confidence Interval 841 to 1185 | Days | |
| Time to Recurrence (TTR) by Independent Assessment | Sorafenib (Nexavar, BAY43-9006) | 1172 | 95% Confidence Interval 924 to NA | Days | |
| Time to Recurrence (TTR) by Independent Assessment | Placebo | 1089 | 95% Confidence Interval 923 to 1260 | Days | |
| Overall Survival (OS) | Sorafenib (Nexavar, BAY43-9006) | NA | 95% Confidence Interval NA to NA | Days | |
| Overall Survival (OS) | Placebo | NA | 95% Confidence Interval NA to NA | Days | |
| Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score | Sorafenib (Nexavar, BAY43-9006) | 0.827 | 95% Confidence Interval 0.804 to 0.85 | Unit on a scale | |
| Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score | Placebo | 0.866 | 95% Confidence Interval 0.843 to 0.888 | Unit on a scale | |
| Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score | Sorafenib (Nexavar, BAY43-9006) | 77.203 | 95% Confidence Interval 75.184 to 79.223 | Unit on a scale | |
| Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score | Placebo | 80.181 | 95% Confidence Interval 78.212 to 82.151 | Unit on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sorafenib (Nexavar, BAY43-9006) | 556 | |
| Overall Study | STARTED | Placebo | 558 | |
| Overall Study | Participants Received Treatment | Sorafenib (Nexavar, BAY43-9006) | 553 | |
| Overall Study | Participants Received Treatment | Placebo | 554 | |
| Overall Study | COMPLETED | Sorafenib (Nexavar, BAY43-9006) | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Sorafenib (Nexavar, BAY43-9006) | 556 | |
| Overall Study | NOT COMPLETED | Placebo | 558 |
Source ClinicalTrials.gov
Adverse events548
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 | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 14 | 548 | 97 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) | 29 | 559 | 217 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 46 | 548 | 115 |
| other | Abdominal pain | Gastrointestinal disorders | Sorafenib (Nexavar, BAY43-9006) | 55 | 559 | 156 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 14 | 548 | 36 |
| other | Abdominal pain upper | Gastrointestinal disorders | Sorafenib (Nexavar, BAY43-9006) | 28 | 559 | 75 |
| other | Ascites | Gastrointestinal disorders | Placebo | 19 | 548 | 67 |
| other | Ascites | Gastrointestinal disorders | Sorafenib (Nexavar, BAY43-9006) | 39 | 559 | 145 |
| other | Constipation | Gastrointestinal disorders | Placebo | 36 | 548 | 122 |
| other | Constipation | Gastrointestinal disorders | Sorafenib (Nexavar, BAY43-9006) | 41 | 559 | 105 |
1 to 10 of 548Source ClinicalTrials.gov
See all 548 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Sorafenib (Nexavar, BAY43-9006) | ||
| Total, other adverse events | Placebo | 360 | |
| Total, other adverse events | Sorafenib (Nexavar, BAY43-9006) | 522 | |
| Total, serious adverse events | Placebo | 230 | 548 |
| Total, serious adverse events | Sorafenib (Nexavar, BAY43-9006) | 228 | 559 |
Source ClinicalTrials.gov
Papers5
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sorafenib (Nexavar, BAY43-9006) vs Placebo: serious adverse events |
Source 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/NCT00692770
GET https://conductscience.org/api/trials/v1/NCT00692770/events?page=2