RecruitingPhase 2NCT07057089

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)


Sponsor

Hebei Medical University Fourth Hospital

Enrollment

90 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CAPOX, a drug called Camrelizumab, and others for people with locally advanced rectal cancer. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

Capecitabine: 825mg/m2, bid;

DRUGCamrelizumab

Camrelizumab: 200mg

DRUGCAPOX

CAPOX

RADIATIONInvolve-field irradiation

Involve-field irradiation: Primary rectal tumor + metastatic or suspicious pelvic lymph nodes, mesorectal region, and presacral region

RADIATIONElective nodal irradiation

Elective nodal irradiation: Large pelvic field

PROCEDURETME surgery

TME surgery


Locations(1)

the Fourth Hospital of Hebei Medical University

Shijiazhuang, China

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NCT07057089


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