Assessment of Efficacy and Safety of PD-1 Monoclonal Antibody Combined With IL-2 and CapeOX in Neoadjuvant Therapy for Locally Advanced Rectal Cancer Prior to Surgery: A Prospective, Multi-center, Randomized Controlled Study

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for locally advanced rectal cancer, which is cancer that hasn't spread but is more difficult to treat. Researchers want to see if a combination of a drug called tislelizumab (which helps the immune system fight cancer), interleukin-2 (a substance that boosts immune response), and a chemotherapy regimen called CapeOX can improve treatment outcomes before surgery. They are particularly interested in patients whose cancer has a specific genetic profile (MSS/pMMR), as this may affect how well the treatment works.

To be eligible for this trial, participants need to be between 18 and 75 years old and have a confirmed diagnosis of rectal cancer that is locally advanced (at least stage T3-T4). They should also have a good performance status, meaning they are generally well enough to participate in the study. However, individuals with more severe conditions, those who have had previous treatments for colorectal cancer, or those with certain autoimmune diseases or infections like HIV will not be eligible. Those who join the trial can expect close monitoring during treatment and will contribute to important research that may help improve future cancer therapies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males and females aged between 18 and 75 years;
• • 2. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• • 3. Histologically confirmed rectal adenocarcinoma;
• • 4. Clinical stage T3-T4 or any T with node-positive (N+) disease: locally advanced;
• • 5. Microsatellite stable (MSS) status;
• • 6. Adequate hematological, hepatic, and renal functions.
• Exclusion Criteria:
• • 1. Patients with metastatic disease (Stage IV); recurrent colorectal cancer with active bleeding, perforation, or complex conditions requiring urgent surgery; or concurrent non-colorectal cancer malignancies.
• • 2. Patients who have previously received systemic anticancer therapy for colorectal cancer; or have been treated with PD-1, PD-L1, or CTLA-4 antibodies.
• • 3. Patients with any active autoimmune disease; known or tested positive for Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS); or a history requiring steroid or immunosuppressive drug treatment.
• • 4. Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis, and acute pneumonia).
• • 5. Patients who experienced any Grade 2 or higher toxicities due to prior treatments (as classified by the Common Terminology Criteria for Adverse Events \[CTCAE\] version 5), which have not resolved (excluding anemia, alopecia, and skin pigmentation changes); known or suspected history of hypersensitivity to any of the drugs used in the trial.
• • 6. Pregnant or breastfeeding women.