Actively 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
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-09-19
35
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged between 18 and 70 years
- ECOG performance status score of 0 or 1
- Histologically confirmed rectal adenocarcinoma from tumor tissue samples
- Adequate hematological function: neutrophil count 1.5 x 10^9/L; platelet count 75 x 10^9/L
- Adequate liver function: serum total bilirubin 1.5 x upper limit of normal; AST 2.5 x upper limit of normal; ALT 2.5 x upper limit of normal
- Adequate kidney function: serum creatinine 1.5 x upper limit of normal
You will not qualify if you...
- Metastatic disease (Stage IV)
- Recurrent rectal cancer
- Concurrent active bleeding, perforation, or complex conditions not manageable by emergency colostomy alone
- Previous systemic anti-cancer treatment for colorectal cancer
- Presence of other non-colorectal malignancies
- Active autoimmune diseases or history of steroid/immunosuppressive drug use
- Interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia)
- Previous treatment-induced grade 2 or higher toxicity not resolved (excluding anemia, hair loss, skin pigmentation)
- Prior treatment with anti-PD-1/PD-L1 or anti-CTLA-4 antibodies
- Pregnant or breastfeeding women
- Known or tested positive for HIV/AIDS
- Known or suspected allergy to any trial drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
Y
Yueming Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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