A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy Followed by Sequential Immunotherapy with CAPOX Combined with PD-1 antibody and IL-2 for Locally Advanced Rectal Cancer
Males and females aged between 18 and 70 years;
ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;
Tumor tissue samples obtained and histologically confirmed as rectal adenocarcinoma;
Adequate hematological, liver, and kidney functions: neutrophil count ≥ 1.5×10^9/L; platelet count ≥ 75×10^9/L; serum total bilirubin ≤ 1.5× upper limit of normal (UNL); aspartate aminotransferase ≤ 2.5× UNL; alanine aminotransferase ≤ 2.5× UNL; serum creatinine ≤ 1.5× UNL.
Metastatic disease (Stage IV);
Recurrent rectal cancer;
Concurrent active bleeding, perforation, or other complex situations that cannot be addressed with emergency colostomy surgery alone;
Previous systemic anti-cancer treatment for colorectal cancer;
The First Affiliated Hospital with Nanjing Medical University
Lead sponsor