Trial intelligence / Profile preview

NeoPulsar: Toripalimab + CAPOX + MR-guided RT for LARC

NCT06840665Phase 2

Key facts

Status: Recruiting
Start: Aug 2024
Primary completion: Aug 2026
Countries: 1
Sponsor: Fudan University
Modality: Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes

Drugs: toripalimab
Conditions: rectal cancer

Overview

Phase 2, randomised, open-label trial of toripalimab in rectal cancer (2 arms), sponsored by Fudan University. Primary endpoint: Pathological Complete Response Rate. Started Aug 2024; status: recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Conventional RT + Toripalimab + CAPOX
Conventional pelvic radiotherapy (30Gy/6Fx) combined with 6 cycles of CAPOX and PD-1 antibody.
LN-sparing RT + Toripalimab + CAPOX
Lymph node-sparing radiotherapy (30Gy/6Fx) combined with 6 cycles of CAPOX and PD-1 antibody.

Who it enrols

Patients with pathologically confirmed rectal adenocarcinoma, clinical stage T3-4 and/or N+, M0, distance from anal verge <= 10 cm, MSS/pMMR status, and adequate organ function.

Endpoints

Primary

Pathological Complete Response Rate1 month after surgery

Secondary

Grade 3-4 Acute Adverse Effects Rateup to 3 months after neoadjuvant therapy
Anal Functionup to 36 months after surgery
Surgical Complication Rate3 months after surgery
3-Year Local Recurrence Free Survival Rate3 years
3-Year Disease Free Survival Rate3 years
3-Year Overall Survival Rate3 years

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