NCT07044921

Clinical Study of Irinotecan Liposome (II)-Based Combination Treatment for Irinotecan-resistant Colorectal Cancer.

A Single-center Phase II Clinical Study of Irinotecan Liposome (II)-Based Combination Regimen as a Treatment for Irinotecan-Resistant Colorectal Cancer.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II clinical study of irinotecan liposome (II)-based combination regimen as a treatment for irinotecan-resistant colorectal cancer.

Detailed description

To observe and evaluate the efficacy and safety of irinotecan liposome (II)-based combination regimen as a treatment for irinotecan-resistant colorectal cancer.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Irinotecan Liposomes (II)+Cetuximab+Bevacizumabl	Irinotecan Liposomes (II) injection：Intravenous infusion, 60 mg/m2, Day 1, Q2W. The recommended initial dosage of irinotecan liposomes (II) for patients with the UGT1A1 \* 28/\* 6 homozygous mutation is 47.1 mg/m2. Cetuximab injection：Intravenous infusion, 500 mg/m2, Day 1, Q2W. Bevacizumabl: Intravenous infusion, 5mg/kg, Day 1, Q2W.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2025-07-01
• Last updated: 2025-07-01

Locations

1 site across 1 country: China