NCT07127497

Clinical Study on the Safety and Relationship of Sintilimab Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma

Safety and Efficacy Evaluation of Neoadjuvant Chemotherapy Without Radiotherapy Combined With Sintilimab for Locally Advanced Rectal Cancer: Short-term Results of a Single-arm Phase 2 Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The First Affiliated Hospital of Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as a single-center, phase II exploratory clinical trial to evaluate the pathological response rate and safety of sintilimab (PD-1 inhibitor) combined with XELOX regimen (oxaliplatin + capecitabine) for neoadjuvant treatment of LARC. The study focuses on the pMMR/MSS patient population and attempts to provide a new treatment option for patients who cannot tolerate radiotherapy or need to preserve organ function.

Conditions

• Pathological Complete Response
• Rectal Cancer
• Neoadjuvant Chemoimmunotherapy

Interventions

Type	Name	Description
BIOLOGICAL	Sintilimab combined with XELOX	Sintilimab (3 mg/kg, IV, qd for patients with body weight \< 60 kg; 200 mg, IV, qd for patients with body weight ≥ 60 kg) combined with XELOX (oxaliplatin 130 mg/m2, IV, qd + capecitabine 1000 mg/m2, bid, d1 - d14, q21d) for 2-4 courses

Timeline

• Start date: 2022-06-01
• Primary completion: 2026-10-01
• Completion: 2028-10-01
• First posted: 2025-08-17
• Last updated: 2025-11-21

Locations

1 site across 1 country: China