Trial · NCT01774344
Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma
NCT01774344, Phase 3, Completed, Bayer; results first posted 2017-06-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma. Trials, record NCT01774344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01774344
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma
- NCT number
- NCT01774344
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 573 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- Regorafenib (Stivarga, BAY73-4506), Placebo
- First posted
- 2013-01-24
- Last updated
- 2020-08-20
- Other registries' IDs
- eudract:2012-003649-14
- Results first posted
- 2017-06-05
- Limitations and caveats
- Decimal places were automatically truncated if last decimal equals zero.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From randomization (Day 1) of the first subject until 419 days later | Overall Survival (OS) was defined as the time from date of randomization (Day 1) to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact. |
| Secondary | Time to Progression (TTP) | From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months) | TTP was the time (days) from randomization to radiological or clinical disease progression assessed by independent radiological review. Median and 95% confidence interval were reported for the modified response evaluation criteria in solid tumors (mRECIST) and response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) analysis sets. Subjects still alive at the time of analysis were censored at their last date of last contact. |
| Secondary | Progression Free Survival (PFS) | From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) | Progression Free Survival (PFS) was defined as the time (days) from date of randomization to date of disease progression (radiological or clinical) or death due to any cause, if death occurs before progression was documented. Death in the absence of progression was a PFS event only if it occurred within the 12+1 weeks for subjects who discontinued treatment prior to cycle 8 and 24+2 weeks for subjects who discontinued treatment after to cycle 8 of the last evaluable tumor assessment; PFS were censored at the date of the last evaluable tumor assessment, if it occurred later. Median and 95% confidence interval 95% were reported for the mRECIST and RECIST 1.1 analysis sets. Subjects still alive at the time of analysis were censored at their last date of last contact. |
| Secondary | Objective Tumor Response Rate (ORR) | From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months) | Objective tumor response rate (ORR) was defined as the percentage of subjects whose best tumor response CR or Partial Response (PR) observed during trial period assessed according to the mRECIST criteria and RECIST 1.1. CR= Disappearance of all clinical and radiological evidence of tumor (both target and non-target). Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non target lesions and no appearance of new lesions. Subjects prematurely discontinuing without an assessment were to be considered non-responders for the analysis. |
| Secondary | Disease Control Rate (DCR) | From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months) | Disease control rate (DCR) was defined as the percentage of subjects whose best response was CR (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), PR (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or stable disease (SD) (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST and RECIST 1.1 criteria. SD had to be maintained for at least 6 weeks from the first demonstration of that rating. |
| Other | Overall Survival (OS) | From randomization (Day 1) of the first subject to end of follow upto 1710 days | Overall Survival (OS) was defined as the time from date of randomization (Day 1) to death due to any cause |
Source ClinicalTrials.gov
Outcomes6
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 randomization (Day 1) of the first subject until 419 days later | days | MEDIAN | |
| SECONDARY | Time to Progression (TTP) | From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months) | days | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) | From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) | days | MEDIAN | |
| SECONDARY | Objective Tumor Response Rate (ORR) | From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months) | percentage of subjects | NUMBER | |
| SECONDARY | Disease Control Rate (DCR) | From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months) | percentage of subjects | NUMBER | |
| OTHER_PRE_SPECIFIED | Overall Survival (OS) | From randomization (Day 1) of the first subject to end of follow upto 1710 days | 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 |
|---|---|---|---|---|---|
| Overall Survival (OS) | Placebo | 237 | 95% Confidence Interval 192 | days | |
| Overall Survival (OS) | Regorafenib 160 mg (BAY73-4506) | 323 | 95% Confidence Interval 276 | days | |
| Time to Progression (TTP) | Placebo | mRECIST | 45 | 95% Confidence Interval 44 | days |
| Time to Progression (TTP) | Regorafenib 160 mg (BAY73-4506) | mRECIST | 97 | 95% Confidence Interval 87 | days |
| Time to Progression (TTP) | Placebo | RECIST 1.1 | 45 | 95% Confidence Interval 44 | days |
| Time to Progression (TTP) | Regorafenib 160 mg (BAY73-4506) | RECIST 1.1 | 119 | 95% Confidence Interval 87 | days |
| Progression Free Survival (PFS) | Placebo | mRECIST | 45 | 95% Confidence Interval 44 | days |
| Progression Free Survival (PFS) | Regorafenib 160 mg (BAY73-4506) | mRECIST | 95 | 95% Confidence Interval 86 | days |
| Progression Free Survival (PFS) | Placebo | RECIST 1.1 | 45 | 95% Confidence Interval 44 | days |
| Progression Free Survival (PFS) | Regorafenib 160 mg (BAY73-4506) | RECIST 1.1 | 102 | 95% Confidence Interval 87 | days |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 194 | |
| Overall Study | STARTED | Regorafenib 160 mg (BAY73-4506) | 379 | |
| Overall Study | Treated | Placebo | 193 | |
| Overall Study | Treated | Regorafenib 160 mg (BAY73-4506) | 374 | |
| Overall Study | Entered Survival FU | Placebo | 145 | |
| Overall Study | Entered Survival FU | Regorafenib 160 mg (BAY73-4506) | 291 | |
| Overall Study | COMPLETED | Placebo | 132 | |
| Overall Study | COMPLETED | Regorafenib 160 mg (BAY73-4506) | 258 | |
| Overall Study | NOT COMPLETED | Placebo | 62 | |
| Overall Study | NOT COMPLETED | Regorafenib 160 mg (BAY73-4506) | 121 |
Source ClinicalTrials.gov
Adverse events450
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 | Anaemia | Blood and lymphatic system disorders | Placebo | 21 | 193 | 40 |
| other | Anaemia | Blood and lymphatic system disorders | Regorafenib (Stivarga, BAY73-4506) | 57 | 374 | 114 |
| other | Hypothyroidism | Endocrine disorders | Placebo | 1 | 193 | 1 |
| other | Hypothyroidism | Endocrine disorders | Regorafenib (Stivarga, BAY73-4506) | 29 | 374 | 33 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 10 | 193 | 13 |
| other | Abdominal distension | Gastrointestinal disorders | Regorafenib (Stivarga, BAY73-4506) | 20 | 374 | 24 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 18 | 193 | 22 |
| other | Abdominal pain upper | Gastrointestinal disorders | Regorafenib (Stivarga, BAY73-4506) | 52 | 374 | 85 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 29 | 193 | 43 |
| other | Abdominal pain | Gastrointestinal disorders | Regorafenib (Stivarga, BAY73-4506) | 85 | 374 | 127 |
1 to 10 of 450Source ClinicalTrials.gov
See all 450 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 176 | 193 |
| Total, all-cause mortality | Regorafenib (Stivarga, BAY73-4506) | 324 | 374 |
| Total, other adverse events | Placebo | 162 | 193 |
| Total, other adverse events | Regorafenib (Stivarga, BAY73-4506) | 366 | 374 |
| Total, serious adverse events | Placebo | 92 | 193 |
| Total, serious adverse events | Regorafenib (Stivarga, BAY73-4506) | 194 | 374 |
Source ClinicalTrials.gov
Papers4
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 |
|---|---|
| Regorafenib (Stivarga, BAY73-4506) vs Placebo: deaths from any cause | Trial comparisons |
| Regorafenib (Stivarga, BAY73-4506) vs 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/NCT01774344
GET https://conductscience.org/api/trials/v1/NCT01774344/events?page=2