Clinical Trial

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

Completed Phase 2
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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) and the Pathological Complete Response rate (pCR) in patients with locally advanced rectal cancer who have Microsatellite Stable/Proficient Mismatch Repair (MSS/pMMR) status.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-03-18; most recent amendment 2026-06-22.
Status change: Recruiting → Completed 2026-06-08
Status change: Not Yet Recruiting → Recruiting 2025-08-31
Trial Details
NCT Number NCT06884670
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions Rectal Cancer
Enrollment 130 participants
Start Date 2024-08-18
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-24