Stivarga (regorafenib)

P2, N=21, Completed, First Affiliated Hospital, Sun Yat-Sen University | Not yet recruiting --> Completed | Phase classification: PN/A --> P2

pDuFLOT and pSOX are potential regimens among senior patients with resectable gastric cancer. At this moment, pDuFLOT may be globally used while pSOX should better be applied among East Asian countries. CadCAPOX, SuCAPOX, PemCAPOX and NiCAPOX are considered as potential first-line regimens among HER2-negative senior patients. CadCAPOX and SuCAPOX are probably more fit for East Asian patients currently, while NiCAPOX may be better applied among Western countries and PemCAPOX has the potential of worldwide application. SuCAPOX is a potential regimen among HER2-negative/PD-L1-positive senior patients, while PemCAPOX may also be considered. Currently, standard CAPOX or FOLFOX regimen may still be available for HER2-negative senior patients with CLDN18.2, FGFR2b or MET positivity. Meanwhile, among HER2-positive senior patients, TraCAPOX is still considered to be available. Regarding first-line maintenance treatments, RamP is a potential regimen among HER2-negative or non-specific senior patients, especially those from Western countries. As second-line regimens, FruP and RamP may be potentially available among East Asian and worldwide HER2-negative senior patients respectively, while T-DXd has the potential of global application among HER2-positive counterparts. Concerning third-line or subsequent regimens, T-DXd is potentially available among HER2-positive senior patients, especially from East Asian countries. Among HER2-negative or non-specific patients, RamIRI is a potential regimen, especially among East Asian patients, while nivolumab and regorafenib may still be available at this moment. Meanwhile, nivolumab and other parallel regimens already recommended by guidelines are still potentially available among HER2-negative/CLDN18.2-positive senior patients. As the first network meta-analysis on this topic, our conclusions may not only provide potential supplements for current guidelines, but also reveal the necessity and directions for future clinical and mechanism researches, especially because of the underpowered subgroup data and exploratory nature of regional applicability.

The angiogenesis inhibitors indicated for mCRC in France (ie, bevacizumab, aflibercept, ramucirumab, and regorafenib) were considered. No associations were found with either recency or cumulative duration of exposure, regardless of the exposure estimation method. In this case-control study of arterial dissections or aneurysms in patients receiving targeted therapy for mCRC, the lack of association with angiogenesis inhibitor exposure was reassuring, given the established benefits of these drugs, particularly bevacizumab, for this indication.

P2/3, N=437, Active, not recruiting, Children's Oncology Group | Recruiting --> Active, not recruiting | Initiation date: Jul 2026 --> Nov 2025

PRG4 demonstrated antitumor activities in vivo and shows promise as an adjuvant to enhance therapeutic interventions in HCC.

Clinically, higher DDR2 associated with inferior overall survival in The Cancer Genome Atlas papillary cohort (KIRP), with no consistent association in the clear cell cohort (KIRC). Across in vitro, in vivo, and in silico analyses, DDR2-high papillary contexts exhibit preferential regorafenib sensitivity, nominating DDR2-enriched papillary RCC for biomarker-guided repurposing and motivating protein-level and genetic validation.

Type IV hypersensitivity reaction-related polymorphisms were associated with regorafenib-induced EM.

SDH deficient GIST is a unique subtype of gastrointestinal stromal tumor with distinct clinic-pathological features, diagnostic modalities, therapeutic strategies, and genetic implications as compared to C-kit/PDGFR-alpha mutated GIST.

P3, N=377, Active, not recruiting, Institut du Cancer de Montpellier - Val d'Aurelle | Trial completion date: Sep 2025 --> Sep 2026

Second- and third-line TKIs, such as sunitinib and regorafenib, provide limited benefits, highlighting the urgent need to address resistance mechanisms. These findings uncover a TGF-β1/CCN2/Rack1/PGK1 mechanism linking CAF-mediated metabolic reprogramming to imatinib resistance in GISTs. Targeting CAF-GIST interactions and key metabolic pathways presents a promising therapeutic strategy.

Meta-regression suggested MGMT methylation was associated with improved OS, PFS, DCR, and SD, while male sex was associated with better OS and SD. Overall, regorafenib demonstrated a predictable safety profile in recurrent glioblastoma, with outcomes potentially improved in male patients with MGMT-methylated tumors.

P1, N=20, Suspended, City of Hope Medical Center | Recruiting --> Suspended