RecruitingNot ApplicableNCT05877573

Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced,High-Risk,MSS Rectal Cancer


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

53 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding toripalimab — an immunotherapy drug — to standard chemotherapy and radiation therapy (chemoradiation) before surgery improves outcomes for people with locally advanced rectal cancer that is classified as MSS (a type that typically does not respond well to immunotherapy alone). **You may be eligible if...** - You are 18–75 years old - You have confirmed MSS or pMMR rectal cancer (adenocarcinoma type) - Your cancer is clinical stage T3-T4 with at least one high-risk feature (positive surgical margins, lymphovascular invasion, or involved lateral lymph nodes) - You have not received any prior cancer treatment for this diagnosis - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your rectal cancer is squamous cell type - You have another active cancer - You are allergic to any component of the chemotherapy or immunotherapy - You have an active autoimmune disease (lupus, rheumatoid arthritis, IBD, etc.) - You have HIV, active hepatitis B or C 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

DRUGToripalimab

Toripalimab 240mg,d1,q3w

RADIATIONshort-term radiotherapy

25Gy/5Fx

DRUGOxaliplatin

135mg/m2 d1 q3w

DRUGCapecitabine

1200mg/m2 d1-14 q3w


Locations(1)

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China

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NCT05877573


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