Evaluation of the Efficacy and Safety of Interleucin-2 Combined With PD-1 Monoclonal Antibody and… (NCT06108596) | Clinical Trial Compass
CompletedPhase 2
Evaluation of the Efficacy and Safety of Interleucin-2 Combined With PD-1 Monoclonal Antibody and CAPOX in Preoperative Neoadjuvant Therapy for Mid-low Locally Advanced Rectal Cancer - a Single-center, Single-arm, Open-label Clinical Trail
China33 participantsStarted 2023-10-21
Plain-language summary
Evaluation of the efficacy and safety of interleucin-2 combined with PD-1 monoclonal antibody and CAPOX in preoperative neoadjuvant therapy for mid-lower locally advanced rectal cancer - a single-center, single-arm, open-label clinical trail.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Males and females aged between 18 and 75 years;
✓. Clinical stage T3-T4 or any T with positive lymph nodes (N+): locally advanced;
✓. Microsatellite stable (MSS) or deficient mismatch repair (dMMR) status;
✓. Distance from the anal verge ≤ 12 cm;
✓. Adequate hematologic, hepatic, and renal function.
Exclusion criteria
✕. Metastatic disease (Stage IV); recurrent colorectal cancer with active bleeding, perforation, or complex conditions requiring urgent surgery; or concurrent presence of other non-colorectal malignancies;
✕. Patients who have previously received systemic anticancer therapy for colorectal cancer; or patients treated with PD-1, PD-L1, or CTLA-4 antibodies;
✕. Patients with any active autoimmune disease; known or tested positive for Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS); or a history of treatment with steroids or immunosuppressive drugs;
✕. Rectal or colon cancer located more than 12 cm from the anal verge;
✕. Patients with interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia);
What they're measuring
1
pCR
Timeframe: From the start of initial medication to the final determination via pathology results after surgical treatment, the assessment period will be up to a maximum of 6 months.
Trial details
NCT IDNCT06108596
SponsorThe First Affiliated Hospital with Nanjing Medical University
✕. Patients who experienced any Grade 2 or higher toxicity due to previous treatments (according to Common Terminology Criteria for Adverse Events (CTCAE) version 5), which has not resolved (excluding anemia, alopecia, and skin pigmentation changes); known or suspected allergy to any of the related drugs used in the trial;