TriangleNCT01774344 · STUDY IN CONTEXT
Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Overall Survival (OS) was defined as the time from date of randomization (Day 1) to death due to any cause
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.
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.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- trial label
- Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0005
- source section id
- NCT01774344-om-0005
- source outcome index
- 5
- endpoint
- Overall Survival (OS)
- endpoint definition
- Overall Survival (OS) was defined as the time from date of randomization (Day 1) to death due to any cause
- time origin
- From randomization (Day 1) of the first subject to end of follow upto 1710 days
- analysis role
- exploratory
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0000
- source section id
- NCT01774344-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival (OS)
- endpoint definition
- 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.
- time origin
- From randomization (Day 1) of the first subject until 419 days later
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0001
- source section id
- NCT01774344-om-0001
- source outcome index
- 1
- endpoint
- Time to Progression (TTP)
- endpoint definition
- 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.
- time origin
- 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)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0002
- source section id
- NCT01774344-om-0002
- source outcome index
- 2
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- 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.
- time origin
- 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)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0003
- source section id
- NCT01774344-om-0003
- source outcome index
- 3
- endpoint
- Objective Tumor Response Rate (ORR)
- endpoint definition
- 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.
- time origin
- 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)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0004
- source section id
- NCT01774344-om-0004
- source outcome index
- 4
- endpoint
- Disease Control Rate (DCR)
- endpoint definition
- 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.
- time origin
- 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)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Placebo
- regimen
- Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
- analyzed count
- 194
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01774344-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Regorafenib 160 mg (BAY73-4506)
- regimen
- Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
- analyzed count
- 379
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01774344-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Placebo
- regimen
- Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
- analyzed count
- 194
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01774344-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Regorafenib 160 mg (BAY73-4506)
- regimen
- Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
- analyzed count
- 379
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01774344-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Placebo
- regimen
- Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
- analyzed count
- 194
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01774344-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Regorafenib 160 mg (BAY73-4506)
- regimen
- Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
- analyzed count
- 379
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01774344-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Placebo
- regimen
- Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
- analyzed count
- 194
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01774344-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Regorafenib 160 mg (BAY73-4506)
- regimen
- Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
- analyzed count
- 379
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01774344-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Placebo
- regimen
- Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
- analyzed count
- 194
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01774344-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Regorafenib 160 mg (BAY73-4506)
- regimen
- Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
- analyzed count
- 379
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01774344-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Placebo
- regimen
- Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
- analyzed count
- 194
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01774344-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Regorafenib 160 mg (BAY73-4506)
- regimen
- Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
- analyzed count
- 379
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01774344-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- harm key
- EG000
- source section id
- NCT01774344-ae
- event group key
- EG000
- event group label
- Placebo
- serious affected
- 92
- serious at risk
- 193
- other affected
- 162
- other at risk
- 193
- frequency threshold
- 5
- collection period
- Adverse event data were collected after start of study drug administration until 30 days after end of study treatment over a period of approximately three years
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01774344
- harm key
- EG001
- source section id
- NCT01774344-ae
- event group key
- EG001
- event group label
- Regorafenib (Stivarga, BAY73-4506)
- serious affected
- 194
- serious at risk
- 374
- other affected
- 366
- other at risk
- 374
- frequency threshold
- 5
- collection period
- Adverse event data were collected after start of study drug administration until 30 days after end of study treatment over a period of approximately three years
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice