MedTrace Logo

Liposomal Irinotecan Based FOLFIRI With Bevacizumab in First-line Treatment of Advanced Colorectal Cancer

NCT05969899 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-11-21

No results posted yet for this study

Summary

The goal of this prospective clinical trial is to evaluate efficacy and safety of irinotecan liposomes for first-line treatment of advanced colorectal cancer. The primary endpoint is Objective response rate (ORR) per RECIST 1.1. The secondary endpoints are overall survival (OS), progression-free survival (PFS), disease control rate (DCR) and safety based on NCI-CTCAE 5.0

Conditions

Interventions

DRUG

FOLFIRI+Bevacizumab

irinotecan liposome 60 mg/m2, iv, for at least 90 minutes LV 400 mg/m2, iv, for at least 2 hours FU 400 mg/m2, iv, followed by FU 2400 mg/m2, iv for at least 46 hours bevacizumab 5mg/kg IV. The above scenario is repeated every two weeks. Patients were treated until disease progression, toxic intolerance, initiation of a new antitumor therapy, withdrawal of knowledge, or investigator judgment that subjects should withdraw from study therapy.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Xinxiang li, PhD · Affiliated Cancer Hospital of Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-07-10
Primary Completion
2025-07-10
Completion
2027-02-10

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05969899 on ClinicalTrials.gov