NCT07134218

Neoadjuvant Chemoradiotherapy Combined With Immunotherapy and Anti-angiogenesis in Treating Locally Advanced Rectal Cancer

A National Multicenter, Prospective, Randomized Controlled Study of Serplulimab Injection Combined With Bevacizumab to Improve the Complete Response Rate of Neoadjuvant Therapy for Locally Advanced Stage Intermediate and Low Rectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, randomized phase II trial designed to evaluate the efficacy and safety of short-course neoadjuvant chemoradiotherapy combined with the PD-1 monoclonal antibody serplulimab and the anti-angiogenic agent bevacizumab in patients with previously untreated pMMR/MSS middle and low locally advanced rectal cancer. The study plans to enroll a total of 200 participants (100 in the experimental arm and 100 in the control arm).

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	serplulimab、bevacizumab	short-course radiotherapy 25 Gy in 5 fractions → 2-week break → 2 cycles of FOLFOX + serplulimab + bevacizumab → 2 cycles of FOLFOX + serplulimab.
OTHER	neoadjuvant chemoradiation therapy	short-course radiotherapy 25 Gy in 5 fractions → 2-week break → 4 cycles of FOLFOX alone.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2025-08-21
• Last updated: 2025-08-21

Locations

1 site across 1 country: China