Actively Recruiting
A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy 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 2026-06-03
35
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for locally advanced rectal cancer, which affects many patients worldwide. This study focuses on combining short-course radiotherapy with sequential immunotherapy, including CAPOX chemotherapy, PD-1 antibody, and interleukin-2 (IL-2). This approach aims to improve outcomes such as reducing tumor recurrence and enhancing immune response, especially in patients with tumors that typically respond poorly to immunotherapy. The treatment plan begins with neoadjuvant short-course radiotherapy combined with IL-2, followed by chemotherapy with CAPOX along with PD-1 monoclonal antibodies and IL-2. This combination is designed to work together by enhancing immune cell activity and improving the body's ability to fight the cancer before surgery. The study is conducted at a single center and follows a single-arm design, meaning all participants receive this treatment sequence. Participants will be closely monitored throughout the study, which lasts up to two years. Researchers will assess treatment effects by measuring complete remission rates at two years. Various evaluations include tumor tissue analysis, blood tests to check organ functions, and overall health assessments. Safety and side effects will be tracked regularly to ensure participant well-being during and after the treatment period.
CONDITIONS
Brief Title
A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy 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 blood counts and organ function: neutrophil count 61.5�d710^9/L; platelet count 675�d710^9/L; serum total bilirubin 41.5 times upper limit of normal; AST and ALT 42.5 times upper limit of normal; serum creatinine 41.5 times upper limit of normal
You will not qualify if you...
- Metastatic disease (Stage IV)
- Recurrent rectal cancer
- Active bleeding, perforation, or other conditions needing emergency colostomy surgery
- Previous systemic anti-cancer treatment for colorectal cancer
- Other non-colorectal cancer malignancies
- Active autoimmune diseases or history of needing steroids or immunosuppressive drugs
- Interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases such as diabetes, hypertension, pulmonary fibrosis, or acute pneumonia
- Previous treatment-related grade 2 or higher toxicities not yet resolved (except anemia, hair loss, and skin pigmentation)
- Previous treatment with anti-PD-1, PD-L1, or CTLA-4 antibodies
- Pregnant or breastfeeding women
- Known or suspected HIV/AIDS infection
- Known or suspected allergy to any drugs used in this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Short-course duration as per protocol
Participants receive neoadjuvant short-course radiotherapy combined with IL-2 to prepare the immune environment before further treatment.
Daily visits during radiotherapy period
Duration - As defined by the treatment cycles in the protocol
Participants undergo sequential immunotherapy with CAPOX combined with PD-1 antibody (Sintilimab) and IL-2 to treat locally advanced rectal cancer.
Multiple visits for drug administration and monitoring during treatment cycles
Duration - Up to two years
Participants are monitored for treatment response and safety after completion of therapy.
Regular visits for assessments during follow-up period
Trial Site Locations
Total: 1 location
1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
Y
Yueming Sun
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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