NCT07198165

SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC

Short-Course Radiotherapy Combined With CAPOX and Bevacizumab, With or Without PD-1 Inhibitors, as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC). The hypothesis is that the addition of immunotherapy (PD-1 inhibitor) can significantly improve the complete response (CR) rate and enhance local control while reducing the incidence of distant metastasis. This study will compare the effects of sequential chemoradiotherapy and targeted therapy with or without immunotherapy following short-course radiotherapy, aiming to explore the optimal regimen for total neoadjuvant therapy.

Conditions

• Rectal Cancer
• Rectal Adenocarcinoma
• Rectal Cancer, Radiotherapy
• Rectal Cancer Patients
• Immunotherapy
• Total Neoadjuvant Therapy
• Total Neoadjuvant Treatment
• Targeted Therapy
• Chemoradiotherapy

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor based immunotherapy	Short-course radiotherapy (25Gy/5Fx) followed by 4 cycles of CAPOX regimen (Oxaliplatin 130mg/m² IV infusion, Capecitabine 1000mg/m² orally for 14 days, Q3w) combined with Bevacizumab (7.5mg/kg IV infusion, D1, Q3w) + PD-1 inhibitor (Toripalimab 240mg IV infusion, D1, Q3w).

Timeline

• Start date: 2025-09-05
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: China