18 and older, any sex, with Carcinoma, Hepatocellular. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to Progression-Blinded Independent Central Review (BICR) AssessmentPrimary· Randomization to maximum of 24.1 months
Time to progression is defined as the time from randomization to radiologic disease progression based on blinded independent review (BICR) of imaging scans using modified Response Evaluation Criteria in Solid Tumors assessment (mRECIST) for hepatocellular carcinoma. The primary analysis was performed using Kaplan Meier methods. The median time to progression is reported with one-sided 90% confidence interval. Analysis was performed on the modified Intent to Treat (mITT) Population which comprised of all randomized participants who received at least part of 1 dose of study agent (mapatumumab/pl
Group
Value
95% CI
Sorafenib+Placebo
5.6
4.3 – NA
Sorafenib+Mapatumumab 30 mg/kg
4.1
2.8 – NA
Time to Progression-Investigator AssessmentSecondary· Randomization to maximum of 52.9 months
Time to progression is defined as the time from randomization to radiologic disease progression. The primary analysis was performed using Kaplan Meier methods based on application of mRECIST for hepatocellular carcinoma to investigator assessments. The median time to progression is reported with one-sided 90% confidence interval. NA indicates upper limit was not measurable as one-sided confidence interval is presented.
Group
Value
95% CI
Sorafenib+Placebo
8.3
5.4 – NA
Sorafenib+Mapatumumab 30 mg/kg
6.4
5.4 – NA
Median Overall SurvivalSecondary· Randomization to maximum of 52.9 months
Overall survival is defined as time from randomization to death from any cause. The analysis was performed using Kaplan Meier methods. The median overall survival is reported with one-sided 90% confidence interval. NA indicates upper limit was not measurable as one-sided confidence interval is presented.
Group
Value
95% CI
Sorafenib+Placebo
10.1
8.9 – NA
Sorafenib+Mapatumumab 30 mg/kg
10.0
7.3 – NA
Progression Free Survival-BICR AssessmentSecondary· Randomization to maximum of 24.1 months
Progression free survival is defined as time from randomization to radiologic disease progression or death from any cause. The analysis was performed using Kaplan Meier methods using BICR assessment of imaging scans. The median progression free survival is reported with one-sided 90% confidence interval. NA indicates upper limit was not measurable as one-sided confidence interval is presented.
Group
Value
95% CI
Sorafenib+Placebo
4.3
3.1 – NA
Sorafenib+Mapatumumab 30 mg/kg
3.2
2.7 – NA
Progression Free Survival-Investigator AssessmentSecondary· Randomization to maximum of 52.9 months
Progression free survival is defined as time from randomization to radiologic disease progression or death from any cause. The analysis was performed using Kaplan Meier methods based on application of mRECIST for hepatocellular carcinoma to investigator assessments. The median progression free survival is reported with one-sided 90% confidence interval. NA indicates upper limit was not measurable as one-sided confidence interval is presented.
Group
Value
95% CI
Sorafenib+Placebo
5.4
3.6 – NA
Sorafenib+Mapatumumab 30 mg/kg
4.0
3.4 – NA
Percentage of Participants With Objective Response-BICR AssessmentSecondary· Randomization to maximum of 24.1 months
Objective response rate is defined as the percentage of participants with complete response+partial response according to mRECIST criteria for hepatocellular carcinoma using BICR assessment of imaging scans. The percentage of participants with objective response is reported along with 95% confidence interval.
Group
Value
95% CI
Sorafenib+Placebo
12.5
4.2 – 26.8
Sorafenib+Mapatumumab 30 mg/kg
17.9
7.5 – 33.5
Percentage of Participants With Objective Response-Investigator AssessmentSecondary· Randomization to maximum of 52.9 months
Objective response rate is defined as the percentage of participants with complete response+partial response according to mRECIST criteria for hepatocellular carcinoma to investigator assessments. The percentage of participants with objective response is reported along with 95% confidence interval.
Group
Value
95% CI
Sorafenib+Placebo
7.8
2.2 – 18.9
Sorafenib+Mapatumumab 30 mg/kg
14.6
6.1 – 27.8
Percentage of Participants With Disease Control-BICR AssessmentSecondary· Randomization to maximum of 24.1 months
Disease control rate is the percentage of participants with complete response+partial response+stable disease according to mRECIST criteria for hepatocellular carcinoma. The end point was based on BICR assessment of imaging scans. The percentage of participants with disease control is presented along with 95% confidence interval.
Group
Value
95% CI
Sorafenib+Placebo
92.5
79.6 – 98.4
Sorafenib+Mapatumumab 30 mg/kg
71.8
55.1 – 85.0
Percentage of Participants With Disease Control-Investigator AssessmentSecondary· Randomization to maximum of 52.9 months
Disease control rate is the percentage of participants with complete response+partial response+stable disease according to mRECIST criteria for hepatocellular carcinoma to investigator assessments. The percentage of participants with disease control is presented along with 95% confidence interval.
Group
Value
95% CI
Sorafenib+Placebo
74.5
60.4 – 85.7
Sorafenib+Mapatumumab 30 mg/kg
68.8
53.7 – 81.3
Time to Response-BICR AssessmentSecondary· Randomization to maximum of 24.1 months
Time to response is defined as time from randomization to first partial response or complete response in responders only. Complete Response (CR): Disappearance of intratumoral arterial enhancement in all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions
Group
Value
95% CI
Sorafenib+Placebo
44
41 – 85
Sorafenib+Mapatumumab 30 mg/kg
48
41 – 188
Duration of Response-BICR AssessmentSecondary· Randomization to maximum of 24.1 months
Duration of response is defined as time from first PR or CR to radiologic disease progression; in responders only. CR: Disappearance of intratumoral arterial enhancement in all target lesions. PR: At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the Baseline sum of the diameters of target lesions. Progressive disease (PD): An increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded
Group
Value
95% CI
Sorafenib+Placebo
123
55 – 325
Sorafenib+Mapatumumab 30 mg/kg
127
42 – 372
Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)Secondary· Start of study treatment to maximum of 52.9 months
An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. An SAE is an adverse event resulting in any of the following outcomes: death, life-threatening, inpatient hospitalization, prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or other medically important events that may jeopardize the participant or may require intervention to prevent one of the other outcomes mentioned before. A treatment-emergent
Non-serious AEs
Group
Value
95% CI
Sorafenib+Placebo
47
Sorafenib+Mapatumumab 30 mg/kg
49
SAEs
Group
Value
95% CI
Sorafenib+Placebo
27
Sorafenib+Mapatumumab 30 mg/kg
21
Adverse events — posted to ClinicalTrials.gov
Time frame: Start of study treatment up to maximum of 52.9 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Sorafenib+Placebo
Serious: 27/51 (53%)
Deaths: 40/51
Sorafenib+Mapatumumab 30 mg/kg
Serious: 21/50 (42%)
Deaths: 39/50
Serious adverse events (43 terms)
Reaction
System
Sorafenib+Placebo
Sorafenib+Mapatumumab 30 m…
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mapatumumab is a fully human, agonist monoclonal antibody that activates the cell death pathway in tumor cells by specifically binding to TRAIL-R1 with high affinity. Sorafenib, a multikinase inhibitor, is the standard of care for treatment of patients with advanced hepatocellular carcinoma (HCC). The mechanisms of sorafenib and mapatumumab action suggest that these agents could interact synergistically. This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of mapatumumab in combination with sorafenib in subjects with advanced hepatocellular carcinoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Human Genome Sciences Inc., a GSK Company
Last refreshed: 19 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01258608.