18 and older, any sex, with Advanced Adult Hepatocellular Carcinoma or BCLC Stage C Hepatocellular Carcinoma. 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.
Median Progression Free Survival (PFS)Primary· From the start of therapy until failure to disease progression or death, assessed up to 4 years
Will be monitored using the method of Thall et al. Kaplan-Meier method will be used to estimate median progression free survival (PFS) and the 95% confidence interval. Log rank test, univariate and multivariate Cox proportional hazards regression models will be used to identify prognostic factors for progression free survival (PFS).
Group
Value
95% CI
Treatment (Sorafenib Tosylate, TheraSphere)
10.32
5.78 – 14.36
Median Time to Progression (TTP)Secondary· Up to 4 years
95% credible interval will be estimated. This will be analyzed using Kaplan-Meier method, Log rank test and Cox proportional hazards regression modeling.
Group
Value
95% CI
Treatment (Sorafenib Tosylate, TheraSphere)
10.38
5.78 – 18.76
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0Secondary· Up to 4 years
To evaluate the safety of the combination of sorafenib (sorafenib tosylate) and Yttrium-90; adverse events (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 \[NCI-CTAE v 4.0\]) .
Fatigue
Group
Value
95% CI
Treatment (Sorafenib Tosylate, TheraSphere)
3
Diarrhea
Group
Value
95% CI
Treatment (Sorafenib Tosylate, TheraSphere)
2
Nausea
Group
Value
95% CI
Treatment (Sorafenib Tosylate, TheraSphere)
1
Vomiting
Group
Value
95% CI
Treatment (Sorafenib Tosylate, TheraSphere)
2
Hypertension
Group
Value
95% CI
Treatment (Sorafenib Tosylate, TheraSphere)
4
Thrombocytopenia
Group
Value
95% CI
Treatment (Sorafenib Tosylate, TheraSphere)
1
Hyperbilirubinemia
Group
Value
95% CI
Treatment (Sorafenib Tosylate, TheraSphere)
1
Proteinuria
Group
Value
95% CI
Treatment (Sorafenib Tosylate, TheraSphere)
1
Adverse events — posted to ClinicalTrials.gov
Time frame: adverse events were collected up to 4 years.
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well sorafenib tosylate and yttrium Y 90 glass microspheres work in treating patients with liver cancer that cannot be removed by surgery. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Yttrium Y 90 glass microspheres use glass beads to carry radiation directly to tumor cells without harming normal cells. Giving sorafenib tosylate with yttrium Y 90 glass microspheres may be an effective treatment for liver cancer.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 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 M.D. Anderson Cancer Center
Last refreshed: 30 December 2021
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/NCT01900002.