drugset / Trial / NCT03678428
FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of the trial is to compare the objective response rates of FUDR/Oxaliplatin HAI plus CPT-11 and FOLFOXIRI chemotherapy in patients with initially non-resectable metastatic colorectal cancer liver metastases. The patients will be treated with systemic FOLFOXIRI chemotherapy or FUDR/Oxaliplatin hepatic arterial infusion with CPT-11 systemic chemotherapy.
Timeline
- Start
- 2021-12-31
- Primary completion
- 2022-10-31
- Completion
- 2022-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Floxuridine | Unknown | 0.12 mg/kg | Other |
| Comparator | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 25 mg | Other |
| Background | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |