Dr Francesco Sclafani talks to ecancer about the interim efficacy analysis of the REGINA trial, which is a phase II study evaluating a combination of regorafenib, nivolumab, and short-course radiotherapy as neoadjuvant therapy for patients with stage II-III rectal adenocarcinoma.

The treatment involved an induction phase, short-course radiotherapy, and a consolidation phase, followed by surgery or a watch-and-wait approach.

Among 36 patients, 30% achieved a complete pathological response, and 59% had a major pathological response.

Adverse events occurred in 61% of patients, prompting a planned dose reduction of regorafenib in the second stage to improve safety.

The study met its predefined criteria, suggesting the combination is worth further investigation.