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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06607458 | Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease | PHASE2 | RECRUITING | 90 | — | — | Aug 5, 2025 | Oct 1, 2027 | Jun 1, 2026 | 14 | United States, Czechia +6 |
Hepatic Progression Free Survival
| Arm | Type | Description |
|---|---|---|
| Melphalan/HDS followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab | EXPERIMENTAL | Melphalan/HDS is given as an infusion of Melphalan into the hepatic artery under general anesthesia. This treatment is administered twice, 8 weeks apart. Following 2 treatments with Melphalan/HDS, Trifluridine-tipiracil is given 35 mg/m2 up to a maximum of 80 mg per dose orally twice daily with food on Days 1 through 5 and Days 8 through 12 of each 28-day cycle; and intravenous (IV) bevacizumab 5 mg/kg body weight on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity |
| Trifluridine-tipiracil plus Bevacizumab Alone | ACTIVE_COMPARATOR | Trifluridine-tipiracil plus Bevacizumab is the standard of care for patients with metastatic colorectal cancer. Trifluridine-tipiracil is given 35 mg/m2 up to a maximum of 80 mg per dose orally twice daily with food on Days 1 through 5 and Days 8 through 12 of each 28-day cycle; and intravenous (IV) bevacizumab 5 mg/kg body weight on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity |
| Name | Type | Description |
|---|---|---|
| Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab | DRUG | Trifluridine-tipiracil plus Bevacizumab Alone |
| Trifluridine-tipiracil plus Bevacizumab Alone | DRUG | Trifluridine-tipiracil plus Bevacizumab Alone |
Inclusion Criteria: * Histologically confirmed diagnosis of metastatic colorectal cancer and histologically or cytologically proven CRC metastases that occupy 50% or less of the liver parenchyma. * Patient has liver-dominant metastatic disease. Liver-dominant is defined as the majority of total tum...