Dose Escalation and Expansion Clinical Trial of Irinotecan Liposome Combined With Oxaliplatin and 5-FU/LV Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer

• Status: RECRUITING
• Trial end date: 2026-05-01

Summary

Dose escalation clinical trial: To explore the dose limiting toxicity (DLT) of irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab in first-line treatment of patients with advanced metastatic colorectal cancer, and to estimate the maximum tolerated dose (MTD) of combined administration.

Expansion clinical trial: To evaluate the safety and efficacy of irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab or cetuximab in first-line treatment of patients with advanced metastatic colorectal cancer. Exploratory analysis of ctDNA changes and genetic mutations in patients at baseline.

• Phase: PHASE1

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Collaborator: CSPC Ouyi Pharmaceutical Co., Ltd.
• Treatments: Bevacizumab; Cetuximab; Fluorouracil; irinotecan sucrosofate; Oxaliplatin