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NCT06225622

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

Shanghai Zhongshan Hospital·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Metastatic Colorectal Cancer
Drug/Device/Intervention
Irinotecan Liposome
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shanghai Zhongshan Hospital
Location
Shanghai, China
Timeline & enrollment
Phase
Phase 1
Start date
Mar 11, 2024
End date
May 01, 2026
Enrollment
78 participants
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
Malignant neoplasm of colonMalignant neoplasm: Colon, unspecifiedMalignant neoplasm: Descending colonMalignant neoplasm: Ascending colonMalignant neoplasm: Overlapping lesion of colon
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06225622
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.