Trial Profile

Efficacy and Safety of Neoadjuvant Long-course Chemoradiation Plus Tislelizumab in Mid-low Locally Advanced Rectal Cancer: a Phase II, Multi-center, Open-label, Randomized Controlled Trial (POLARSTAR Trial)

Status: Recruiting

Phase of Trial: Phase II/III

Latest Information Update: 10 Mar 2025

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At a glance

Drugs Tislelizumab (Primary) ; Capecitabine; Programmed cell death-1 ligand-1 inhibitors
Indications Adenocarcinoma; Rectal cancer
Focus Proof of concept; Therapeutic Use
Acronyms POLAR-STAR

01 Feb 2025 Primary endpoint has been met (pCR rate) , according to Results published in the Nature Medicine
01 Feb 2025 Results (n=186) from phase II portion published in the Nature Medicine
04 Jun 2024 Results assessing the efficacy and safety of adding PD1 inhibitors to the neoadjuvant long-course chemoradiation of LARC patients with this phase 2, randomized, controlled trial were presented at the 60th Annual Meeting of the American Society of Clinical Oncology.

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