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 - Trial NCT06225622
Access comprehensive clinical trial information for NCT06225622 through Pure Global AI's free database. This Phase 1 trial is sponsored by Shanghai Zhongshan Hospital and is currently Recruiting. The study focuses on Metastatic Colorectal Cancer. Target enrollment is 78 participants.
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Study Focus
Sponsor & Location
Shanghai Zhongshan Hospital
Timeline & Enrollment
Phase 1
Mar 11, 2024
May 01, 2026
Primary Outcome
Maximum-tolerated dose,Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06225622
Non-Device Trial