NCT07020468

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

A Clinical Study on the Efficacy and Safety of Oxaliplatin + Irinotecan Liposome + 5-FU/LV as Neoadjuvant Therapy for Locally Advanced Colon and Upper Rectal Cancer

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Affiliated Cancer Hospital of Shantou University Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a single-center, single-arm, prospective clinical trial. A total of 57 patients are expected to be enrolled over 24 months, with a 1-year follow-up observation period. Eligible participants who meet the inclusion criteria and do not meet the exclusion criteria will receive neoadjuvant treatment with irinotecan liposome combined with oxaliplatin + 5-FU/LV (NALIRIFOX). Treatment will be administered in 2-week cycles for 3-6 cycles, and surgery will be planned for those who meet surgical criteria. For those who do not meet surgical criteria, the subsequent treatment plan will be decided by the investigator. Postoperative adjuvant therapy will be determined by the investigator based on the patient's condition. The primary endpoint is the major pathological response (MPR) rate, and secondary endpoints include pathological complete response (pCR), R0 resection rate, objective response rate (ORR), disease control rate (DCR), disease-free survival (DFS), and safety. 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.

Conditions

• Colorectal Cancer (CRC)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-15
• Primary completion: 2025-07-30
• Completion: 2027-05-31
• First posted: 2025-06-13
• Last updated: 2025-06-13

Locations

1 site across 1 country: China