Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02112656 | Study of ThermoDox With Standardized Radiofrequency Ablation (RFA) for Treatment of Hepatocellular Carcinoma (HCC) | PHASE3 | COMPLETED | 554 | — | — | Jun 1, 2014 | Apr 27, 2020 | Aug 20, 2024 | 61 | United States, Canada +12 |
| NCT00617981 | Phase 3 Study of ThermoDox With Radiofrequency Ablation (RFA) in Treatment of Hepatocellular Carcinoma (HCC) | PHASE3 | COMPLETED | 701 | — | — | May 1, 2008 | Aug 1, 2016 | May 3, 2024 | 79 | United States, Canada +9 |
| NCT00441376 | A Study of ThermoDox™ in Combination With Radiofrequency Ablation (RFA) in Primary and Metastatic Tumors of the Liver | PHASE1 | COMPLETED | 30 | — | — | Feb 1, 2007 | Dec 1, 2009 | Feb 7, 2019 | 1 | United States |
Overall survival is defined as the time (in months) from the date of randomization to the death from any cause or the end of the study.
| Arm | Type | Description |
|---|---|---|
| ThermoDox 50 mg/m2 | EXPERIMENTAL | ThermoDox plus standardized RFA using standardized treatment dwell time for solitary HCC lesions ≥ 3.0 cm to ≤ 7.0 cm |
| Dummy infusion | PLACEBO_COMPARATOR | standardized RFA alone using standardized treatment dwell time for solitary HCC lesions ≥ 3.0 cm to ≤ 7.0 cm |
| ThermoDox + RFA | EXPERIMENTAL | ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins. |
| Sham + RFA | SHAM_COMPARATOR | Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins. |
| Name | Type | Description |
|---|---|---|
| ThermoDox | DRUG | Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion |
| Dummy infusion | DRUG | Sodium Chloride 0.9% or 5% Dextrose (D5W), Single 30 minute intravenous infusion |
| 5% Dextrose Solution | DRUG | Single 30 minute intravenous infusion |
Inclusion Criteria: 1. Male or female ≥ 18 years of age. 2. Diagnosed with a single HCC lesion ≥ 3.0 cm but ≤ 7.0 cm in maximum diameter based on diagnosis at screening. * Subjects meeting the American Association for the Study of Liver Disease (AASLD) criteria may be randomized without a biops...