Rationale and design of REGINA, a phase II trial of neoadjuvant regorafenib, nivolumab, and short-course radiotherapy in stage II and III rectal cancer

A retrospective cohort study of neoadjuvant chemoradiotherapy combined with immune checkpoint inhibitors in locally advanced rectal cancer

“…After further analysis of stratified treatment effects based on the general population and different subgroups, although the descent stage rate was different in the subgroups based on NRAS, BRAF, CD4, and CD8 expressions, there was no significant difference in sphincter preservation rate, indicating that NRAS, BRAF, CD4, and CD8 may be predictive indexes for descent stage rate. To date, some study protocols of phase II clinic trials of short-course radiotherapy combined with neoadjuvant chemotherapy or PD-1 inhibitor have been reported [ 41 , 42 ]. Their findings will further aid in optimizing upcoming treatment combinations and perhaps even improving patient selection.…”

Case report: long-term sustained remission in a case of metastatic colon cancer with high microsatellite instability and KRAS exon 2 p.G12D mutation treated with fruquintinib after local radiotherapy: a case report and literature review

“…Only a few studies have reported using sequentially administered TKIs and RT or TKIs combined with RT. A clinical trial named REGINA aims to evaluate the survival benefits of neoadjuvant regorafenib in combination with nivolumab and short-course RT for stage II and III rectal cancer, the results of which are highly anticipated ( Bregni et al, 2021 ). A previous case showed that a patient with metastatic hepatocellular carcinoma achieved long-term survival of over 71 months after receiving a combination of regorafenib and RT ( Kim et al, 2023 ).…”

Neoadjuvant Therapy for Hepatocellular Carcinoma

“…132,135 Other TKIs, such as lenvatinib, regorafenib, and cabozantinib, have been administrated as NATs in multiple solid tumors, such as thyroid cancer, renal cell carcinoma, and rectal cancer, and promising results were observed, but few studies have been published on TKIs as NATs for HCC. [140][141][142][143][144] Finally, to evaluate the survival variation of LR/LT after TKIs, a statistical model that allows personalized survival prediction using baseline clinical features is warranted. 145,146 According to the high expression level of molecular markers such as BRAF-V600E and EGFR in tumor biopsy specimens or peripheral blood, a dual-targeted therapy strategy with multiple targets is also worthy of investigation.…”