RecruitingPhase 2NCT06577194

A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy With IL-2 Followed by Sequential Immunotherapy With CAPOX Combined With PD-1 Antibody and IL-2 for Locally Advanced Rectal Cancer


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

35 participants

Start Date

Oct 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy with IL-2 Followed by Sequential Immunotherapy with CAPOX Combined with PD-1 antibody and IL-2 for Locally Advanced Rectal Cancer


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment approach for locally advanced rectal cancer that combines short-course radiation therapy with an immune-boosting protein (IL-2) followed by chemotherapy and an immunotherapy drug (PD-1 antibody), to try to eliminate the cancer without always needing surgery. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with rectal cancer (adenocarcinoma) confirmed by tissue sample - You are in good physical health (ECOG 0 or 1) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have serious heart, autoimmune, or immune system conditions - You have previously received chemotherapy or radiation for rectal cancer 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

DRUGSintilimab + IL-2 Combined with CAPOX

Sintilimab + IL-2 Combined with Capox

RADIATIONShort-course radiotherapy

Short-course radiotherapy+IL-2


Locations(1)

Jiangsu Province Hospital

Nanjing, Jiangsu, China

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NCT06577194


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