NCT07057089

Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I)

Clinical Exploration of Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer: a Prospective, Open-label, Randomized Controlled Trial (Neo-Field I)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	Capecitabine: 825mg/m2, bid;
DRUG	Camrelizumab	Camrelizumab: 200mg
DRUG	CAPOX	CAPOX
RADIATION	Involve-field irradiation	Involve-field irradiation: Primary rectal tumor + metastatic or suspicious pelvic lymph nodes, mesorectal region, and presacral region
RADIATION	Elective nodal irradiation	Elective nodal irradiation: Large pelvic field
PROCEDURE	TME surgery	TME surgery

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-03-01
• Completion: 2030-12-01
• First posted: 2025-07-09
• Last updated: 2025-08-14

Locations

1 site across 1 country: China