Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer

NCT06341296 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2024-08-12

No results posted yet for this study

Summary

To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients.

Conditions

Interventions

DRUG

Irinotecan Liposome

70 mg/m\^2 , d1, 14 days per cycle, 8 cycles.

DRUG

5-FU

5-FU 400mg/m\^2, then 2400mg/m\^2, continuous intravenous infusion for 46-48h, d1-2, 14 days per cycle, 8 cycles.

DRUG

LV

400mg/m\^2, d1, 14 days per cycle, 8 cycles.

DRUG

Bevacizumab

5mg/kg, d1, 14 days per cycle, 8 cycles.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2026-04-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06341296 on ClinicalTrials.gov