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

NCT07057089 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-08-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    lead OTHER

Principal Investigators

  • Fengpeng Wu · Hebei Medical University Fourth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2028-03-01
Completion
2030-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07057089 on ClinicalTrials.gov