Actively Recruiting
Assessment of Efficacy and Safety of PD-1 Monoclonal Antibody Combined With IL-2 and CapeOX in Neoadjuvant Therapy for Locally Advanced Rectal Cancer Prior to Surgery: A Prospective, Multi-center, Randomized Controlled Study
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-09-08
130
Participants Needed
4
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective is to evaluate whether the neoadjuvant combination of tislelizumab (a PD-1 inhibitor) with interleukin-2 (IL-2) chemotherapy can significantly increase the Objective Response Rate (ORR) and the Pathological Complete Response rate (pCR) in patients with locally advanced rectal cancer who have Microsatellite Stable/Proficient Mismatch Repair (MSS/pMMR) status.
CONDITIONS
Official Title
Assessment of Efficacy and Safety of PD-1 Monoclonal Antibody Combined With IL-2 and CapeOX in Neoadjuvant Therapy for Locally Advanced Rectal Cancer Prior to Surgery: A Prospective, Multi-center, Randomized Controlled Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged between 18 and 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Histologically confirmed rectal adenocarcinoma
- Clinical stage T3-T4 or any T with node-positive (N+) disease indicating locally advanced cancer
- Microsatellite stable (MSS) status
- Adequate hematological, liver, and kidney functions
You will not qualify if you...
- Metastatic disease (Stage IV), recurrent colorectal cancer with active bleeding, perforation, or requiring urgent surgery
- Concurrent non-colorectal cancer malignancies
- Previous systemic anticancer therapy for colorectal cancer
- Previous treatment with PD-1, PD-L1, or CTLA-4 antibodies
- Active autoimmune disease or HIV/AIDS infection
- History of steroid or immunosuppressive drug use
- Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases such as diabetes or hypertension
- Any unresolved Grade 2 or higher toxicities from prior treatments (except anemia, alopecia, or skin pigmentation changes)
- Known or suspected allergy to study drugs
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Nanjing BenQ Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
2
Jiangsu province hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
3
Xuzhou Central hospital
Xuzhou, Jiangsu, China
Actively Recruiting
4
The Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Actively Recruiting
Research Team
Y
Yueming Sun
CONTACT
Y
Yue Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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