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New Second-Line Combo Therapy for MSS Metastatic Colorectal Cancer

NCT07559760 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-30

No results posted yet for this study

Summary

This is a single-center, single-arm study designed to evaluate the efficacy and safety of second-line treatment in patients with advanced colorectal cancer (those who have progressed on or are intolerant to first-line oxaliplatin-based regimens with or without targeted therapy) receiving Levofolinic Acid + 5-FU continuous infusion combined with irinotecan hydrochloride liposome ± cetuximab/bevacizumab. Approximately 30 patients will be enrolled.

Conditions

Interventions

DRUG

Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab

Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab 1. Irinotecan HCl liposome 70 mg/m² IV over 90 min, Day 1, every 2 weeks * UGT1A1\*28 7/7 homozygotes: start at 50 mg/m²; escalate to 70 mg/m² from cycle 2 if well tolerated. * Premedication per liposomal irinotecan label. 2. Levofolinic Acid 200 mg/m² + 5-FU 2 400 mg/m², both placed in the same ambulatory pump and infused continuously over 46-48 h starting Day 1. 3. Targeted agent (physician's choice): * Bevacizumab 5 mg/kg IV, Day 1, every 2 weeks, or * Cetuximab 500 mg/m² IV, Day 1, every 2 weeks, or 400 mg/m² first dose then 250 mg/m² weekly. Liposomal irinotecan is given for a maximum of 12 cycles until progression or unacceptable toxicity. Upon investigator decision, patients may switch to maintenance: Levofolinic Acid + 5-FU continuous infusion ± bevacizumab/cetuximab.

Sponsors & Collaborators

  • The First Hospital of Jilin University

    lead OTHER

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
2025-11-01
Primary Completion
2027-05-31
Completion
2029-05-31

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 NCT07559760 on ClinicalTrials.gov