Trial intelligence / Profile preview

AK104 + Neoadjuvant Chemoradiotherapy in pMMR/MSS LARC

NCT05980689Phase 2

Key facts

Status: Recruiting
Start: Oct 2023
Primary completion: Jun 2024
Countries: 1
Sponsor: Sun Yat-sen University
Modality: Bispecific Antibodies

Drugs: cadonilimab
Conditions: rectal cancer

Overview

Phase 2, open-label, single-arm trial of cadonilimab in rectal cancer, sponsored by Sun Yat-sen University. Primary endpoint: Complete response (CR) rate at 6 months. Started Oct 2023; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Treatment Arm
Neoadjuvant CRT + AK104 followed by consolidation AK104 and surgery

Who it enrols

Patients with pMMR/MSS locally advanced rectal cancer (cT3-4aNany or cT1-4aN+), PD-L1 positive (TPS>=1% or CPS>=1).

Endpoints

Primary

Complete response (CR) rate6 months

Secondary

Adverse effects5 years
Rate of Major pathologic response and tumor regression grade distribution1 year
Rate of surgical complications1 year
Disease free survival36 months
Local recurrence free survival36 months
Overall survival60 months
Long-term anal function1.5 years

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