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
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 (PICM)
The First Affiliated Hospital with Nanjing Medical University
130 participants
Mar 18, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Tislelizumab 200mg ivd D1+Interleukin 2 100IU HD, d1-d14+ CapeOX (Capecitabine: 825mg/m2 bid po, d1-d14;Oxaliplatin 200 mg/m² ivd, d1)
Radiotherapy 1.8Gy per time\*28
Tislelizumab 200mg ivd D1
Oxaliplatin 200 mg/m² ivd, d1
Capecitabine: 825mg/m2 bid po, d1-d14
Locations(4)
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NCT06884670