Trial · NCT01004978
Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
NCT01004978, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2023-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery. Trials, record NCT01004978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01004978
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
- NCT number
- NCT01004978
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 235 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma
- Interventions
Cisplatin, Computed Tomography, Doxorubicin Hydrochloride, Doxorubicin-Eluting Beads, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Mitomycin, Pharmacological Study, Placebo Administration, Sorafenib Tosylate
- First posted
- 2009-10-30
- Last updated
- 2024-01-03
- Results first posted
- 2023-02-17
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years | PFS is defined to be the time from randomization to progression or death without evidence of progression. For cases without documentation of progression, follow-up will be censored at the date of last disease assessment without progression, unless death occurs within 4 months following the date last known progression-free, in which case the death will be counted as an event. Progression is assessed per Solid Tumor Response Criteria (RECIST) and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. |
| Secondary | Overall Survival (OS) | Assessed every 3 months for 2 years and then every 6 months for 2 years | Overall survival (OS) is defined as time from randomization to death from any cause, censoring cases who had not died at the date last known alive. |
| Secondary | Progression-free Survival (PFS) Among Patients With Extra-hepatic Progression | Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years | PFS is defined to be the time from randomization to progression or death without evidence of progression. Progression is assessed per Solid Tumor Response Criteria (RECIST) and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. For patients with progressive disease, the progression was classified as either intra- or extra-hepatic or both intra- and extra-hepatic. Patients with both intra- and extra-hepatic progression were considered as having extra-hepatic progression. This analysis was performed among patients with extra-hepatic progression. |
| Secondary | Progression-free Survival (PFS) Among Patients With Intra-hepatic Progression | Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years | PFS is defined to be the time from randomization to progression or death without evidence of progression. Progression is assessed per Solid Tumor Response Criteria (RECIST) and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. For patients with progressive disease, the progression was classified as either intra- or extra-hepatic or both intra- and extra-hepatic. This analysis was performed among patients with intra-hepatic progression. |
| Other | Pharmacogenetic and Pharmacokinetic Properties of Sorafenib Including Angiogenesis, Monooxygenases, Polymorphisms and Multidrug Resistance Mutation (MDR) | Assessed at baseline, days 1, 8 and 15 of cycle 1 sorafenib, 3-5 days prior to 2nd and 3rd TACE | This analysis will be performed across a few ECOG-ACRIN studies of sorafenib to evaluate the association between genotypes that are related with sorafenib activity and clinical outcomes. |
| Other | Inter-reader Concordance for Response by EASL (European Association for the Study of the Liver) Criteria | at 4 months and 8 months Assessed at 4 months and 8 months following initial chemoembolization | Response was determined using the European Association for the Study of the Liver (EASL) criteria, which was recommended as an alternative to RECIST for grading therapeutic response of advanced hepatocellular carcinoma (HCC). The EASL criteria use the longest dimension of enhancing tumor as the primary metric for gauging tumor response. The Kappa statistics will be applied to assess agreement between readers. |
| Other | Association Between Objective Tumor Response by EASL Criteria and PFS as Well as OS | Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years | PFS is defined to be the time from randomization to progression or death without evidence of progression. For cases without documentation of progression, follow-up will be censored at the date of last disease assessment without progression, unless death occurs within 4 months following the date last known progression-free, in which case the death will be counted as an event. Progression is assessed per Solid Tumor Response Criteria (RECIST) and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. OS is defined as time from randomization to death or date last known alive. Response is assessed at 4 and 8 months by EASL criteria. |
| Other | To Evaluate the Effects of Intra-hepatic vs. Extra-hepatic Progression on OS. | Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years | Progression is assessed per Solid Tumor Response Criteria (RECIST) and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. For patients with progressive disease, the progression was classified as either intra- or extra-hepatic or both intra- and extra-hepatic. OS is defined as the time from randomization to death or date last known alive. |
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 | Progression-free Survival (PFS) | Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years | All randomized patients | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Assessed every 3 months for 2 years and then every 6 months for 2 years | All randomized patients | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) Among Patients With Extra-hepatic Progression | Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years | Only patients with extra-hepatic progression (as well as those with both intra- and extra-hepatic progression) are included in this analysis | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) Among Patients With Intra-hepatic Progression | Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years | Only patients with intra-hepatic progression are included in this analysis. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Pharmacogenetic and Pharmacokinetic Properties of Sorafenib Including Angiogenesis, Monooxygenases, Polymorphisms and Multidrug Resistance Mutation (MDR) | Assessed at baseline, days 1, 8 and 15 of cycle 1 sorafenib, 3-5 days prior to 2nd and 3rd TACE | |||
| OTHER_PRE_SPECIFIED | Inter-reader Concordance for Response by EASL (European Association for the Study of the Liver) Criteria | at 4 months and 8 months Assessed at 4 months and 8 months following initial chemoembolization | |||
| OTHER_PRE_SPECIFIED | Association Between Objective Tumor Response by EASL Criteria and PFS as Well as OS | Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years | |||
| OTHER_PRE_SPECIFIED | To Evaluate the Effects of Intra-hepatic vs. Extra-hepatic Progression on OS. | Assessed 4 months after first chemoembolization, 8 months after first chemoembolization, then every 8 weeks, up to 4 years |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Arm A (Sorafenib and TACE) | 9.3 | 95% Confidence Interval 6.8 to 11.9 | months | |
| Progression-free Survival (PFS) | Arm B (Placebo and TACE) | 8.4 | 95% Confidence Interval 5.4 to 10.9 | months | |
| Overall Survival (OS) | Arm A (Sorafenib and TACE) | 19.8 | 95% Confidence Interval 16.8 to 23.7 | months | |
| Overall Survival (OS) | Arm B (Placebo and TACE) | 19.9 | 95% Confidence Interval 13.5 to 27.2 | months | |
| Progression-free Survival (PFS) Among Patients With Extra-hepatic Progression | Arm A (Sorafenib and TACE) | 6.83 | 95% Confidence Interval 3.7 to 15.7 | months | |
| Progression-free Survival (PFS) Among Patients With Extra-hepatic Progression | Arm B (Placebo and TACE) | 5.6 | 95% Confidence Interval 5.0 to 9.7 | months | |
| Progression-free Survival (PFS) Among Patients With Intra-hepatic Progression | Arm A (Sorafenib and TACE) | 8.5 | 95% Confidence Interval 5.8 to 11.1 | months | |
| Progression-free Survival (PFS) Among Patients With Intra-hepatic Progression | Arm B (Placebo and TACE) | 7.8 | 95% Confidence Interval 4.9 to 10.7 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Sorafenib and TACE) | 118 | |
| Overall Study | STARTED | Arm B (Placebo and TACE) | 117 | |
| Overall Study | COMPLETED | Arm A (Sorafenib and TACE) | 0 | |
| Overall Study | COMPLETED | Arm B (Placebo and TACE) | 0 | |
| Overall Study | NOT COMPLETED | Arm A (Sorafenib and TACE) | 118 | |
| Overall Study | NOT COMPLETED | Arm B (Placebo and TACE) | 117 |
Source ClinicalTrials.gov
Adverse events150
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 | Anemia | Blood and lymphatic system disorders | Arm A (Sorafenib and TACE) | 6 | 110 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Placebo and TACE) | 11 | 108 | |
| other | Fatigue | General disorders | Arm A (Sorafenib and TACE) | 15 | 110 | |
| other | Fatigue | General disorders | Arm B (Placebo and TACE) | 13 | 108 | |
| other | Palmar-plantar erythrodysesthesia | Skin and subcutaneous tissue disorders | Arm A (Sorafenib and TACE) | 8 | 110 | |
| other | Palmar-plantar erythrodysesthesia | Skin and subcutaneous tissue disorders | Arm B (Placebo and TACE) | 1 | 108 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm A (Sorafenib and TACE) | 6 | 110 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm B (Placebo and TACE) | 7 | 108 | |
| other | Diarrhea | Gastrointestinal disorders | Arm A (Sorafenib and TACE) | 8 | 110 | |
| other | Diarrhea | Gastrointestinal disorders | Arm B (Placebo and TACE) | 3 | 108 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Sorafenib and TACE) | 85 | 118 |
| Total, all-cause mortality | Arm B (Placebo and TACE) | 88 | 117 |
| Total, other adverse events | Arm A (Sorafenib and TACE) | 22 | 110 |
| Total, other adverse events | Arm B (Placebo and TACE) | 21 | 108 |
| Total, serious adverse events | Arm A (Sorafenib and TACE) | 65 | 110 |
| Total, serious adverse events | Arm B (Placebo and TACE) | 41 | 108 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Sorafenib and TACE) vs Arm B (Placebo and TACE): deaths from any cause | Trial comparisons |
| Arm A (Sorafenib and TACE) vs Arm B (Placebo and TACE): 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/NCT01004978
GET https://conductscience.org/api/trials/v1/NCT01004978/events?page=2