Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT07020468
PHASE4

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

Sponsor: Affiliated Cancer Hospital of Shantou University Medical College

View on ClinicalTrials.gov

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

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.

Locations (1)

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China