RecruitingPhase 2NCT06884670

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)


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

130 participants

Start Date

Mar 18, 2025

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining immunotherapy (a PD-1 checkpoint inhibitor), a type of immune-boosting molecule (IL-2), and chemotherapy (CapeOX) before surgery can improve outcomes for people with locally advanced rectal cancer that has a specific genetic profile (called microsatellite stable or MSS). **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced rectal cancer confirmed by biopsy - Your tumor has not spread to distant organs - Your cancer is classified as MSS (microsatellite stable) - You have not previously received chemotherapy or immunotherapy for colorectal cancer **You may NOT be eligible if...** - Your cancer has spread (Stage IV) or requires emergency surgery - You have HIV, an active autoimmune disease, or need immunosuppressive medications - You have lung inflammation, uncontrolled diabetes, hypertension, or other serious conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInterleukin-2

Tislelizumab 200mg ivd D1+Interleukin 2 100IU HD, d1-d14+ CapeOX (Capecitabine: 825mg/m2 bid po, d1-d14;Oxaliplatin 200 mg/m² ivd, d1)

RADIATIONRadiotherapy

Radiotherapy 1.8Gy per time\*28

DRUGTislelizumab

Tislelizumab 200mg ivd D1

DRUGOxaliplatin

Oxaliplatin 200 mg/m² ivd, d1

DRUGCapecitabine

Capecitabine: 825mg/m2 bid po, d1-d14


Locations(4)

Nanjing BenQ Hospital

Nanjing, Jiangsu, China

Jiangsu province hospital

Nanjing, Jiangsu, China

Xuzhou Central hospital

Xuzhou, Jiangsu, China

The Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

View Full Details on ClinicalTrials.gov

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NCT06884670


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