NCT05957016

Neoadjuvant CIETAI With Concurrent Chemoradiotherapy in Local Advanced Rectal Cancer

Neoadjuvant Preoperative Arterial Intervention With Concurrent Chemoradiotherapy in Local Advanced Rectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Based our previous multi-center randomized controlled study (Preoperative arterial perfusion Chemo- embolization combined with radiotherapy for locally advanced rectal cancer, NCT03601156), the idea of "preoperative arterial chemo-immuno-embolization combined with radiotherapy for locally advanced rectal cancer (CIETAI-R)" was proposed. This is also the serial study of CIETAI that explore the efficacy of tumor arterial chemo-immuno-embolization in lung cancer, LARC, metastatic liver cancer.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-30
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2023-07-24
• Last updated: 2023-08-23

Locations

1 site across 1 country: China