NCT06493240

Neoadjuvant Long-course Chemoradiotherapy Followed by Immunotherapy for Locally Advanced Mid-low Rectal Cancer

Neoadjuvant Long-course Chemoradiotherapy Followed by PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the effect of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab (PD-1 inhibitor) in patients with locally advanced rectal cancer.

Detailed description

Investigator designed a single-arm, open-label, phase II trial and the purpose of this study is to observe and evaluate the efficacy and safety of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab (PD-1 inhibitor) for locally advanced rectal cancer.Participants will accept capecitabine-based long-term radiotherapy(50.4Gy radiation) followed by 200mg Sintilimab each time for 3 times, with 2-week intervals. The primary endpoint is pCR rate, and secondary endpoints include sphincter-preserving rate, adverse event rates.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
RADIATION	radiation	45 Gy radiation dose in 25 fractions to the pelvis
DRUG	PD-1 Monoclonal Antibody	200mg Sintilimab after radiation (3 times, 2-week interval)
PROCEDURE	TME surgery	TME surgery for 6\~8 weeks after radiation

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2024-07-09
• Last updated: 2025-11-25

Locations

1 site across 1 country: China