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Neoadjuvant Therapy (NALIRIFOX) for Locally Advanced Colon and Upper Rectal Cancer
Sponsor: Affiliated Cancer Hospital of Shantou University Medical College
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
57
Start Date
2025-05-15
Completion Date
2027-05-31
Last Updated
2025-06-13
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China