RecruitingPhase 2NCT06455124

Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)


Sponsor

Fudan University

Enrollment

60 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study (TORCH-LE) tests whether short-course radiation combined with a chemotherapy regimen (capecitabine + oxaliplatin, called CapeOx) and a PD-1 immunotherapy drug can safely replace full radical surgery in patients with early rectal cancer that was removed by local excision but has high-risk features suggesting incomplete treatment. **You may be eligible if...** - You are aged 18–75 with rectal cancer that was removed by local excision (not full bowel resection) - Your tumor is within 7 cm of the anus and was found to have high-risk features (e.g., positive margins, deep invasion, lymphovascular invasion, high grade) - You have refused radical surgery - You have not received any prior cancer treatment - Your cancer is microsatellite stable (MSS/pMMR) **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your cancer has spread to the pelvis or other organs - You have a serious medical condition such as uncontrolled heart disease or severe infection - You have a DPD enzyme deficiency (which affects how capecitabine is broken down) 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

RADIATIONRadiation

Shor-course radiotherapy: 25Gy/5Fx

DRUGPD-1 antibody

PD-1 antibody (Toripalimab): 240mg d1 q3w

DRUGCapecitabine

Capecitabine: 1000mg/m2 d1-14 q3w

DRUGOxaliplatin

Oxaliplatin: 130mg/m2 d1 q3w


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT06455124


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