Status:
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
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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) ...
Detailed Description
Colorectal cancer (CRC) stands as a prominent global health concern, ranking among the most prevalent malignancies worldwide. Its incidence exhibits striking geographical variations, with higher rates...
Eligibility Criteria
Inclusion
- Males and females aged between 18 and 75 years;
- An 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: locally advanced;
- Microsatellite stable (MSS) status;
- Adequate hematological, hepatic, and renal functions.
Exclusion
- Patients with metastatic disease (Stage IV); recurrent colorectal cancer with active bleeding, perforation, or complex conditions requiring urgent surgery; or concurrent non-colorectal cancer malignancies.
- Patients who have previously received systemic anticancer therapy for colorectal cancer; or have been 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 requiring steroid or immunosuppressive drug treatment.
- Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis, and acute pneumonia).
- Patients who experienced any Grade 2 or higher toxicities due to prior treatments (as classified by the Common Terminology Criteria for Adverse Events \[CTCAE\] version 5), which have not resolved (excluding anemia, alopecia, and skin pigmentation changes); known or suspected history of hypersensitivity to any of the drugs used in the trial.
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
March 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 10 2027
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06884670
Start Date
March 18 2025
End Date
July 10 2027
Last Update
September 8 2025
Active Locations (4)
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1
Nanjing BenQ Hospital
Nanjing, Jiangsu, China, 210000
2
Jiangsu province hospital
Nanjing, Jiangsu, China, 210029
3
Xuzhou Central hospital
Xuzhou, Jiangsu, China
4
The Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China