Trial · NCT01015833
Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer
NCT01015833, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2018-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer. Trials, record NCT01015833. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01015833
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer
- NCT number
- NCT01015833
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 356 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Advanced Adult Hepatocellular Carcinoma, Recurrent Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v7, Stage IIIA Hepatocellular Carcinoma AJCC v7, Stage IIIB Hepatocellular Carcinoma AJCC v7, Stage IIIC Hepatocellular Carcinoma AJCC v7, Stage IV Hepatocellular Carcinoma AJCC v7, Stage IVA Hepatocellular Carcinoma AJCC v7, Stage IVB Hepatocellular Carcinoma AJCC v7, Unresectable Hepatocellular Carcinoma
- Interventions
- Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Pharmacogenomic Study, Sorafenib Tosylate
- First posted
- 2009-11-18
- Last updated
- 2026-06-24
- Results first posted
- 2018-05-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Up to 3 years | Overall survival is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method. |
| Secondary | Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 3 years | Toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below. |
| Secondary | Progression Free Survival | Up to 3 years | Progression free survival is defined as the time from study entry to earliest date of disease progression. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions is also considered progression). |
| Secondary | Time to Progression (TTP) | Up to 3 years | Time to Progression (TTP) is defined as the time from on study to progression. Progression is defined by the RECIST criteria as Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions is also considered progression). Median and 95% confidence intervals are provided for each arm below. |
| Secondary | Best Overall Response Rate | Up to 3 years | Best Overall Response Rate is defined as is the best response recorded from the start of the treatment until disease progression/recurrence. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Up to 3 years | month | MEDIAN | |
| SECONDARY | Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 3 years | percentage of patients | NUMBER | |
| SECONDARY | Progression Free Survival | Up to 3 years | months | MEDIAN | |
| SECONDARY | Time to Progression (TTP) | Up to 3 years | months | MEDIAN | |
| SECONDARY | Best Overall Response Rate | Up to 3 years | Patients who started treatment and had follow-up assessments were included in this analysis. | percentage of patients | NUMBER |
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 | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | 8.9 | 95% Confidence Interval 7.1 to 10.8 | month | |
| Overall Survival | Arm II (Sorafenib Tosylate) | 10.5 | 95% Confidence Interval 7.6 to 13.8 | month | |
| Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | Fatigue | 10 | percentage of patients | |
| Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Arm II (Sorafenib Tosylate) | Fatigue | 7 | percentage of patients | |
| Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | Hypertension | 3 | percentage of patients | |
| Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Arm II (Sorafenib Tosylate) | Hypertension | 13 | percentage of patients | |
| Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | White blood cells | 11 | percentage of patients | |
| Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Arm II (Sorafenib Tosylate) | White blood cells | 0 | percentage of patients | |
| Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | Neutrophils | 33 | percentage of patients | |
| Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Arm II (Sorafenib Tosylate) | Neutrophils | 0 | percentage of patients |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | 180 | |
| Overall Study | STARTED | Arm II (Sorafenib Tosylate) | 176 | |
| Overall Study | COMPLETED | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | 167 | |
| Overall Study | COMPLETED | Arm II (Sorafenib Tosylate) | 171 | |
| Overall Study | NOT COMPLETED | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | 13 | |
| Overall Study | NOT COMPLETED | Arm II (Sorafenib Tosylate) | 5 |
Source ClinicalTrials.gov
Adverse events536
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 I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | 10 | 167 | 11 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Sorafenib Tosylate) | 8 | 171 | 8 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | 0 | 167 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm II (Sorafenib Tosylate) | 1 | 171 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | 5 | 167 | 7 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (Sorafenib Tosylate) | 0 | 171 | 0 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | 1 | 167 | 1 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm II (Sorafenib Tosylate) | 0 | 171 | 0 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | 1 | 167 | 1 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm II (Sorafenib Tosylate) | 0 | 171 | 0 |
1 to 10 of 536Source ClinicalTrials.gov
See all 536 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | 12 | 167 |
| Total, all-cause mortality | Arm II (Sorafenib Tosylate) | 16 | 171 |
| Total, other adverse events | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | 146 | 167 |
| Total, other adverse events | Arm II (Sorafenib Tosylate) | 151 | 171 |
| Total, serious adverse events | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | 71 | 167 |
| Total, serious adverse events | Arm II (Sorafenib Tosylate) | 57 | 171 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | 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 I (Doxorubicin Hydrochloride, Sorafenib Tosylate) vs Arm II (Sorafenib Tosylate): deaths from any cause | Trial comparisons |
| Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) vs Arm II (Sorafenib Tosylate): 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/NCT01015833
GET https://conductscience.org/api/trials/v1/NCT01015833/events?page=2