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Neoadjuvant Therapy （NALIRIFOX） for Locally Advanced Colon and Upper Rectal Cancer

NCT07020468 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-06-13

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluating the efficacy and safety of Oxaliplatin + Irinotecan Liposome + 5-FU/LV in patients with Locally Advanced Colorectal Cancer and Upper Rectal Cancer. Patients would be included as:1. Aged between 18-75 years, with no gender restrictions; 2. Biopsy pathology confirmed as advanced colon cancer and upper rectal cancer; 3. Clinical staging of T3N+ or T4Nany with initially resectable tumors; 4. No distant metastasis observed in routine chest and abdominal CT scans.

The main question it aims to answer is Major Pathological Response Rate, referring to the proportion of patients who experience a significant reduction in the size of their tumor or near-complete pathological regression after treatment, typically assessed through a biopsy or surgical resection.

Participants will be Chemotherapy administered before surgery, with 3-6 cycles of treatment, using the chemotherapy regimen of Oxaliplatin + Irinotecan Liposome + 5-FU/LV.

Conditions

  • Colorectal Cancer (CRC)

Interventions

DRUG

NALIRIFOX

The patients with Locally Advanced Colorectal Cancer and Upper Rectal Cancer will undergo neoadjuvant treatment with irinotecan liposome combined with oxaliplatin + 5-FU/LV (NALIRIFOX), with each treatment cycle lasting 2 weeks, for a total of 3-6 cycles.

Sponsors & Collaborators

  • Affiliated Cancer Hospital of Shantou University Medical College

    lead OTHER

Principal Investigators

  • Muming Xv · Affiliated Cancer Hospital of Shantou University Medical College

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
2025-05-15
Primary Completion
2025-07-30
Completion
2027-05-31

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 NCT07020468 on ClinicalTrials.gov