Neoadjuvant Short-Course Radiotherapy Followed by CAPOX Plus PD-1 Antibody and IL-2 in Locally Advanced Rectal Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Sintilimab + IL-2 Combined with CAPOX
  • Short-course radiotherapy

Treatment groups

35 Participants
are divided into 1 treatment group