RecruitingPhase 3NCT07070622

Planed Organ Preservation for Low Rectal Cancer After Neoadjuvant Chemotherapy (OPLAR)

Planed Organ Preservation for Early- and Intermediate-risk Low Rectal Cancer With Good Response to Neoadjuvant Chemotherapy


Sponsor

West China Hospital

Enrollment

186 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

On the basis of our previous study, this project further explored whether patients with effective neoadjuvant chemotherapy can obtain a higher organ preservation rate after total neoadjuvant therapy. This study was designed to enroll patients with low and intermediate-risk rectal cancer. After 2 cycles of XELOX chemotherapy, patients with effective chemotherapy as judged by high-definition MRI of the rectum (the long diameter of the tumor was shortened by ≥30% compared with that before treatment) were randomly divided into two groups. One group was long-course chemoradiotherapy combined with consolidation chemotherapy (TNT group). In the other group, long-term chemoradiotherapy combined with immunotherapy and consolidation chemotherapy (iTNT group), we explored whether TNT could achieve a higher organ preservation rate after effective neoadjuvant chemotherapy in patients with low and intermediate-risk low rectal cancer, and the organ preservation rate of TNT combined with immunotherapy.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether rectal cancer patients who respond very well to chemotherapy before surgery can safely avoid surgery and preserve their rectum (organ preservation). Instead of removing the rectum, patients who show a near-complete or complete response would be closely monitored. **You may be eligible if...** - You are 18 to 80 years old - You have rectal cancer confirmed by pathology - Your tumor is located in the lower part of the rectum - Your cancer does not have a specific mutation (MSI-H) that would make immunotherapy more appropriate **You may NOT be eligible if...** - Your tumor is in the upper rectum or colon - Your cancer has already spread to distant organs (Stage IV) - You have already received treatment for this cancer - You are not able to undergo the required imaging tests 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

DRUGpatients were assigned to receive TNT or iTNT management

TNT or iTNT


Locations(1)

West China Hospital

Chengdu, Sichuan, China

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NCT07070622


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