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RECRUITING
NCT06840665
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2024-08-13

Completion Date

2027-02-12

Last Updated

2025-02-21

Healthy Volunteers

No

Interventions

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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China