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

NCT07044921 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-01

No results posted yet for this study

Summary

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

Conditions

  • Colorectal Cancer Metastatic

Interventions

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.

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Guanghai Dai, Doctor · Chinese PLA General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-07-31
Completion
2027-07-31

Countries

  • China

Study Locations

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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 NCT07044921 on ClinicalTrials.gov