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Updated: Sep 10, 2025

Robot-assisted Total Mesorectal Excision and Lateral Pelvic Lymph Node Dissection for Locally Advanced Middle-low Rectal Cancer

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Dual Immune Checkpoint Inhibition Plus Neoadjuvant Chemoradiotherapy in Rectal Cancer: A Randomized Clinical Trial.

Johannes Laengle¹, Irene Kuehrer¹, Askin Kulu¹

¹Division of Visceral Surgery, Department of General Surgery, Comprehensive Cancer Center Vienna, Medical University of Vienna, Vienna, Austria.

JAMA Network Open

|August 22, 2025

Summary

Adding ipilimumab and nivolumab to neoadjuvant chemoradiotherapy (CRT) for rectal cancer was safe and feasible. While not significantly improving complete response rates, this combination showed promising clinical activity in a phase 2 trial.

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Intramucosal Inoculation of Squamous Cell Carcinoma Cells in Mice for Tumor Immune Profiling and Treatment Response Assessment

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Published on: April 22, 2019

Area of Science:

Oncology
Immunotherapy
Gastrointestinal Oncology

Background:

Microsatellite-stable rectal cancer is often resistant to immune checkpoint inhibitors (ICIs).
Radiotherapy can enhance tumor immunogenicity, suggesting a potential benefit from combining radiotherapy with ICIs.
The added benefit of combining CTLA-4 inhibitors with PD-1 inhibitors in neoadjuvant rectal cancer regimens requires further investigation.

Purpose of the Study:

To evaluate the safety and feasibility of combining ipilimumab (an anti-CTLA-4 antibody) and nivolumab (an anti-PD-1 antibody) with neoadjuvant chemoradiotherapy (CRT) for rectal cancer.
To assess surgical complications and reoperation rates as primary outcomes.
To determine clinical and pathological response rates as secondary outcomes.

Main Methods:

A prospective, randomized, open-label, multicenter phase 2 clinical trial (CHINOREC) was conducted.
Patients received neoadjuvant CRT (50 Gy with capecitabine) alone or with sequential ipilimumab and nivolumab.
Surgical resection was performed 10–12 weeks after CRT, with intention-to-treat analysis.

Main Results:

The combination of CRT with ipilimumab and nivolumab was safe and feasible, with no statistically significant increase in surgical complications or reoperation rates compared to CRT alone.
Surgical complication rates were 77% in both groups (any grade).
Major pathological response and complete response rates were high in both arms, with no significant difference between groups.

Conclusions:

Integrating ipilimumab and nivolumab into neoadjuvant CRT for rectal cancer is safe and feasible, without increasing surgical complications.
The dual ICI regimen demonstrated promising clinical activity, although complete response rates did not significantly improve.
Further research is warranted to optimize treatment strategies, including timing, dosing, and patient selection for combined radiotherapy and ICI therapy.