NCT06462053

Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer

A Prospective, Randomized, Phase II Trial of Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.

Conditions

• Early Low Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Short-course radiotherapy	Short-course radiotherapy: 25Gy/5Fx
DRUG	PD-1 antibody (Toripalimab)	Toripalimab 240mg d1 q3w
RADIATION	Long-course radiotherapy	Long-course radiation: 50Gy/25Fx
DRUG	Oxaliplatin	Oxaliplatin: 130mg/m2 d1 q3w
DRUG	Capecitabine	Xeloda

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-04-01
• Completion: 2027-03-01
• First posted: 2024-06-17
• Last updated: 2024-06-17

Locations

1 site across 1 country: China