Liposomal Irinotecan Plus Bevacizumab in Irinotecan-refractory Metastatic Colorectal Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT06434090
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liposomal irinotecan — DRUG
    Liposomal irinotecan will be given biweekly at a dose from 70mg/m2 to 90mg/m2.
  • Bevacizumab — DRUG
    bevacizumab will be given biweekly at a dose of 5mg/m2

Study Details

To evaluate the efficacy and safety of liposomal irinotecan plus bevacizumab in irinotecan-refractory metastatic colorectal cancer

Key Dates

First listed
May 30, 2024
Start date
Jun 5, 2024
Status verified
May 2024
Primary completion
Jun 5, 2025
Completion
Jul 1, 2026

Study Design

Enrollment
74 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Liposomal irinotecan plus bevacizumab
    Patients received Liposomal irinotecan (a '3+3' design was adopted in the experimental arm, with 3 dose levels of 70mg/m2, 80mg/m2, and 90mg/m2 for dose exploration) every 2 weeks (Q2W). bevacizumab, 5mg/m2, every 2 weeks The two-drug combination therapy was continued every 2 weeks in a cycle until patients developed disease progression or met other criteria for termination of study treatment specified in the protocol.

Primary Outcome Measure

Maximum tolerated dose (MTD) of liposomal irinotecan [ Time Frame: 1 months ]

Central Contacts

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