drugset
drugset / Trial / NCT06884670

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

NCT06884670 ↗

Phase 2 Completed 130 enrolled The First Affiliated Hospital with Nanjing Medical University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-08-18
Primary completion
2026-05-31
Completion
2026-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous
Subject aldesleukin Protein / enzyme biologic 1e+06 iu Subcutaneous
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications

rectal cancer