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RECRUITING
NCT07057089
PHASE2

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

Sponsor: Hebei Medical University Fourth Hospital

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-07-01

Completion Date

2030-12-01

Last Updated

2025-08-14

Healthy Volunteers

No

Interventions

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

Locations (1)

the Fourth Hospital of Hebei Medical University

Shijiazhuang, China