NCT07527026

A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant Therapy in Locally Advanced Low pMMR/MSS Rectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In pMMR/MSS locally advanced rectal cancer, can the innovative "chemo-immunotherapy induction + LCRT + chemo-immunotherapy consolidation" approach significantly improve the complete response rate and create opportunities for organ preservation?

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab	patients first receive 2 cycles of camrelizumab combined with CAPOX (capecitabine 1000 mg/m² orally twice daily on days 1-14; oxaliplatin 130 mg/m² intravenously every 3 weeks). This is followed by long-course chemoradiotherapy (LCRT): a total dose of 50.4 Gy delivered in 28 fractions, with concurrent capecitabine 825 mg/m² orally twice daily.

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-02-01
• Completion: 2029-02-01
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: China