drugset / Trial / NCT07099794
A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen
Phase 2
Not yet recruiting
90 enrolled
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, two-cohort, multicenter Phase II clinical study. To evaluate the efficacy and safety of liposomal irinotecan II and 5-FU/LV combined with or without renvastinib in the treatment of patients with advanced biliary system tumors, 90 patients were scheduled to be enrolled.
Timeline
- Start
- 2025-08-01
- Primary completion
- 2029-02-28
- Completion
- 2029-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 8 mg | Oral |
| Subject | Lenvatinib | Small molecule | 12 mg | Oral |
| Background | IRINOTECAN | Small molecule | 56.5 mg/m2 | Intravenous |
| Background | LV | Unknown | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 1200 mg/m2 | Intravenous |