NCT07014540

A Irinotecan Liposome Trial of in Advanced Neuroendocrine Carcinoma

Clinical Study on the Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV in the Treatment of Advanced Neuroendocrine Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Beijing GoBroad Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To explore the efficacy and safety of irinotecan liposome injection combined with 5-FU/LV in the treatment of advanced neuroendocrine carcinoma (NEC)

Detailed description

1\. Irinotecan hydrochloride liposome injection combined with 5-FU/LV therapy in a 2-week treatment cycle ,until disease progresses or intolerable toxicity Drug: Liposome irinotecan(50-70mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle Drug: LV (400mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle Drug: 5-FU(2400mg/m\^2) will be administered by continuous infusion for 46 hours on day 1 in a 2-week treatment cycle

Conditions

• Neuroendocrine Carcinomas (NEC)

Interventions

Type	Name	Description
DRUG	Irinotecan Hydrochloride Liposome Injection	Liposome irinotecan (70/50mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week
DRUG	5-FU	5-FU (2400mg/m\^2) will be administered by continuous infusion for 46 hours in a 2-week
DRUG	LV	LV (400mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week

Timeline

• Start date: 2025-06-20
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-06-11
• Last updated: 2025-06-11

Locations

1 site across 1 country: China