Response-adapted Total Neoadjuvant Therapy Guided by Induction Chemotherapy in Early- and Intermediate-risk Low Rectal Cancer for Implementation of a Watch-and-wait Strategy

Sponsor
West China Hospital
Study ID
NCT07260526
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Study Details

This study investigates the feasibility of an organ-preserving "watch-and-wait" strategy in patients with mid-to-low rectal cancer who achieve a good response after total neoadjuvant therapy (TNT). By retrospectively and prospectively analyzing patients who complete TNT following effective induction chemotherapy, the study aims to assess organ preservation rates and evaluate whether non-surgical management can provide comparable oncologic outcomes to radical surgery while improving functional recovery and quality of life.

Key Dates

First listed
Dec 3, 2025
Start date
Oct 1, 2025
Status verified
Dec 2025
Primary completion
Oct 1, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: ITNT group
    Patients who achieve a good response after total neoadjuvant therapy and receive organ preservation strategy

Primary Outcome Measure

1-year organ preservation rate [ Time Frame: 1 year after completion of neoadjuvant radiotherapy ]

Central Contacts

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