Status:
RECRUITING
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
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Rectal Cancer
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 Ca...
Detailed Description
Globally, there are around 732,000 new cases of rectal cancer annually, with locally advanced rectal cancer (T3-4 or N+) comprising a significant proportion. The current NCCN guidelines recommend neoa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06577194
Start Date
October 5 2024
End Date
October 31 2028
Last Update
September 19 2025
Active Locations (1)
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1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210000