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drugset / Trial / NCT06840665

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

NCT06840665 ↗

Phase 2 Recruiting 46 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-08-13
Primary completion
2026-08-12
Completion
2027-02-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 —
Subject Oxaliplatin Small molecule 130 mg/m2 —
Subject Toripalimab Monoclonal antibody 240 mg —

Indications

No indication recorded.