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RECRUITING
NCT07070622
PHASE3

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

Sponsor: West China Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

186

Start Date

2024-11-01

Completion Date

2029-12-31

Last Updated

2025-07-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

patients were assigned to receive TNT or iTNT management

TNT or iTNT

Locations (1)

West China Hospital

Chengdu, Sichuan, China