Status:
COMPLETED
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
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Locally Advanced Rectal Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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-cent...
Detailed Description
The global incidence rate of rectal cancer is approximately 732,000 cases/year, of which a significant proportion is locally advanced rectal cancer (i.e., T3-4 or N+). Currently, for locally advanced ...
Eligibility Criteria
Inclusion
- Males and females aged between 18 and 75 years;
- ECOG performance status score of 0 or 1;
- Histologically confirmed rectal adenocarcinoma;
- 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
- 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);
- 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;
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
October 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06108596
Start Date
October 21 2023
End Date
December 31 2024
Last Update
January 21 2025
Active Locations (1)
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1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210000