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Neoadjuvant CIETAI With Concurrent Chemoradiotherapy in Local Advanced Rectal Cancer

NCT05957016 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-08-23

No results posted yet for this study

Summary

To increase the efficacy of neoadjuvant PD-1/PD-1 checkpoint inhibitor in local advanced rectal cancer (LARC), we propose preoperative arterial infusion of Tirellizumab and oxaliplatin followed by tumor artery embolization with concurrent chemoradiotherapy as neoadjuvant regimen for LARC.

Conditions

Interventions

PROCEDURE

CIETAI-R

1. phase I: (1) Chemo-Immulo-embolization via Tumor Arterial, CIETAI: DSA guided tumor artery infusion of oxaliplatin 130 mg/m2+PD-1 inhibitor (Tirelizumab) 200mg, followed by gelatin sponge particles (350-560um) embolization 2. phase II: Chemoradiotherapy: IMRT：45Gy/25f/5w+capecitabine 1000，po. Bid d1-14, q3w Tirelizumab)200mg ivggt, d1, q3w

Sponsors & Collaborators

  • Third Military Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-30
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05957016 on ClinicalTrials.gov