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Trifluridine-tipiracil plus Bevacizumab Alone · 1 trial · 1 indication
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...
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Trifluridine-tipiracil plus Bevacizumab Alone is being studied for the treatment of refractory metastatic colorectal cancer. It is an investigational combination regimen evaluated in a Phase 2 clinical trial for patients with liver-dominant disease. The regimen is being tested as an active control arm in the study.
Trifluridine-tipiracil plus Bevacizumab Alone is being developed by Delcath Systems, Inc., a company traded under the ticker DCTH. The company is conducting a Phase 2 clinical trial to evaluate this regimen in patients with refractory metastatic colorectal cancer.
Trifluridine-tipiracil plus Bevacizumab Alone is in Phase 2 clinical development. It is an investigational regimen and is not yet approved by regulatory authorities. The ongoing trial is actively recruiting participants to assess its safety and efficacy in refractory metastatic colorectal cancer.
Trifluridine-tipiracil plus Bevacizumab Alone is being evaluated in clinical trial NCT06607458. This Phase 2 study is recruiting 90 patients with refractory metastatic colorectal cancer and liver-dominant disease. The trial is active in the United States, Czechia, Germany, Italy, Netherlands, Serbia, Spain, and Turkey.
Trifluridine-tipiracil plus Bevacizumab Alone refers to the regimen of trifluridine-tipiracil combined with bevacizumab, used as a standalone treatment arm in the clinical trial. It is compared against a treatment that includes high-dose melphalan delivered directly into the liver followed by approved cancer treatment.