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ACTIVE NOT RECRUITING
NCT07038122
NA

Reducing the Resection Range After Neoadjuvant Therapy for Locally Advanced Upper Rectal and Rectosigmoid Junction Cancers

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn evaluate the safety and efficacy of reduced surgical resection margins in patients with local advanced upper rectal or rectosigmoid junction tumors who met the ycT≤3N0M0 regression following neoadjuvant therapy. The main questions it aims to answer are: Does reduced surgical resection margins (3 cm of distal margin and 5 cm of proximal margin) meet the radical resection criteria, including the rate of negative resection margin, the number of lymph node harvested? How is the surgical safety of reduced surgical resection, including the surgical duration , bleeding, recovery time and postoperative complications? Is reduced surgical margins resection (3 cm of distal margin and 5 cm of proximal margin) inferior to conventional surgical margins resection (5 cm of distal margin and 10 cm of proximal margin) in terms of oncology safety?

Official title: Reducing the Resection Range After Neoadjuvant Therapy for Locally Advanced Upper Rectal and Rectosigmoid Junction Cancers: A Prospective, Multicenter, Randomized Controlled Phase 3 Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

874

Start Date

2025-07-01

Completion Date

2028-06-20

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

PROCEDURE

Laparoscopic resection

Laparoscopic resection of bowel and corresponding mesentery.

OTHER

Neoadjuvant Therapy

Neoadjuvant Therapy aims to downstage the tumor including different chemotherapy, targeted therapy and immunotherapy.

Locations (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China