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

NCT07070622 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2025-07-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

patients were assigned to receive TNT or iTNT management

TNT or iTNT

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07070622 on ClinicalTrials.gov