What type of study is this?

This is a Pre-Registered Trial study.

May 6, 2026Open Access

Total neoadjuvant chemotherapy combined with PD‑1 blockade and IL‑2 in MSS/pMMR locally advanced rectal cancer: short-term results of a prospective, single-arm phase II study

Key Points

To evaluate the efficacy and safety of total neoadjuvant chemotherapy combined with PD-1 blockade and IL-2 in advanced rectal cancer.
Single-arm phase II trial design
Patients with MSS/pMMR locally advanced rectal cancer
Intervention included neoadjuvant chemotherapy, PD-1 blockade, and IL-2
Evaluation of tumor microenvironment and outcomes
Improvements in tumor microenvironment observed with IL-2 treatment
High efficacy noted with promising safety profile
Study supports further validation of this regimen in rectal cancer treatment.

Abstract

T cells, NK cells, and M1 macrophage subsets in the tumor microenvironment of patients achieving pCR. These compelling data demonstrate promising efficacy with a favorable safety profile in MSS/pMMR LARC. These findings warrant studies to validate this regimen as a novel treatment paradigm for rectal cancer. ClinicalTrials.gov registration: NCT06108596.

Total neoadjuvant chemotherapy combined with PD‑1 blockade and IL‑2 in MSS/pMMR locally advanced rectal cancer: short-term results of a prospective, single-arm phase II study

Key Points

Abstract

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