RecruitingPhase 2NCT06577194

A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy With IL-2 Followed by Sequential Immunotherapy With CAPOX Combined With PD-1 Antibody and IL-2 for Locally Advanced Rectal Cancer

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

35 participants

Start Date

Oct 5, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Rectal Cancer

Summary

A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy with IL-2 Followed by Sequential Immunotherapy with CAPOX Combined with PD-1 antibody and IL-2 for Locally Advanced Rectal Cancer

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

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.

Exclusion Criteria12

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;
Coexistence of other non-colorectal cancer malignancies;
Patients with any active autoimmune diseases, or a history of needing steroids or immunosuppressive drugs;
Patients with interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia);
Previous treatment-induced any grade 2 or above toxicity reaction (according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5 classification) that has not subsided (excluding anemia, hair loss, and skin pigmentation);
Previous treatment with anti-programmed death receptor-1 (PD-1) or its ligand (PD-L1) antibodies, anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibodies;
Pregnant or breastfeeding women;
Known or tested positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
Known or suspected allergy history to any drugs used in the trial.