Trials / Recruiting
RecruitingNCT06184698
Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer
Liposomal Irinotecan + Leucovorin + 5-fluorouracil + Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer (IRIS)：a Multicenter, Single-arm, Prospective, Phase II Study
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 173 (estimated)
- Sponsor
- Hebei Medical University Fourth Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, single-arm study to investigate the efficacy and safety of liposomal irinotecan+5-FU/LV+ bevacizumab as second-line therapy in metastatic colorectal cancer in Chinese population.
Detailed description
Colorectal cancer (CRC) has a poor prognosis and poses a serious threat to human health. FOLFIRI (irinotecan+5-FU/LV) / FOLFOX (oxaliplatin+5-FU/LV) ± angiogenesis inhibitors are common treatments for advanced CRC. For patients receiving oxaliplatin-based therapy, irinotecan-based therapy is recommended as second-line therapy. Liposomal irinotecan is a new pharmaceutical form of traditional irinotecan. It adopts a special loading technology to encapsulate traditional irinotecan in liposomes, which can avoid its hydrolysis under physiological conditions, increase the affinity with cancer cells, overcome drug resistance, increase the drug uptake by cancer cells, reduce the drug dose, improve the efficacy and reduce the toxic side effects. The aim of this study is to explore the efficacy and safety of liposomal irinotecan+5-FU/LV + bevacizumab as second-line treatment for metastatic CRC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | liposomal irinotecan | liposomal irinotecan 70 mg/m² |
| DRUG | 5-FU | 5-FU 2400 mg/m² |
| DRUG | LV | 5-FU 2400 mg/m² |
| DRUG | Bevacizumab | bevacizumab 5 mg/kg |
Timeline
- Start date
- 2024-01-01
- Primary completion
- 2026-02-01
- Completion
- 2027-03-01
- First posted
- 2023-12-28
- Last updated
- 2024-10-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06184698. Inclusion in this directory is not an endorsement.