NCT06840665

MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

A Prospective, Randomized, Phase II Trial of MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy/6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. The primary endpoint is pathological complete response (pCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal function, surgical complication, 3-year LRFS rate, 3-year DFS rate, 3-year OS rate, etc.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
DRUG	PD-1 antibody	PD-1 antibody (Toripalimab): 240mg d1 q3w
DRUG	Oxaliplatin	Oxaliplatin: 130mg/m2 d1 q3w
DRUG	Capecitabine	Capecitabine: 1000mg/m2 bid d1-14 q3w

Timeline

• Start date: 2024-08-13
• Primary completion: 2026-08-12
• Completion: 2027-02-12
• First posted: 2025-02-21
• Last updated: 2025-02-21

Locations

1 site across 1 country: China