Fruzaqla (fruquintinib)

We analyzed global and Chinese CRLM clinical trials from the Informa database, focusing on fruquintinib, sintilimab, and dual immunotherapy (CTLA-4 + PD-1). Targets analysis shows most have low safety and specificity, but CD34, FLT1, and TP53 exhibit good profiles and potential for CRLM therapy and prognosis. This study, by integrating and analyzing the clinical trial data related to CRLM, aims to conduct an in-depth investigation and evaluate the safety specificity of the treatment targets through reference.

Limitations include heterogeneity across studies, with most conducted in predominantly Chinese cohorts. Further studies should explore optimal combination strategies and biomarker-based selection.

P2, N=90, Recruiting, Kahr Bio Australia Pty Ltd | Not yet recruiting --> Recruiting

No EA-related toxicity was observed. Overall, EA plus fruquintinib and sintilimab was feasible and showed an acceptable safety profile while maintaining antitumor activity in MSS-mCRC, warranting further evaluation in larger randomized trials.

In the real-world setting, fruquintinib combined with immunotherapy was associated with benefits in third-line treatment of patients with pMMR mCRC. Shorter metastasis-to-PD2 interval and elevated baseline CA19-9 levels at the start of third-line therapy were independent poor prognostic factors.

Although this is a small-sample retrospective study, it preliminarily validates the synergistic effect of programmed death 1 inhibitors combined with fruquintinib and docetaxel in MSS/pMMR CRC, providing a novel strategy with translational significance for later-line treatment in advanced patients.

P2, N=50, Recruiting, The Methodist Hospital Research Institute | Not yet recruiting --> Recruiting | Initiation date: Aug 2025 --> Dec 2025

Moreover, fruquintinib improved tumor responses to nab-paclitaxel and inhibited nab-paclitaxel-induced ex vivo differentiation of M-LECP. Finally, in silico analysis of VEGFR3/FLT4/CD310 expression in samples from cancer patients revealed higher expression of VEGFR3/FLT4/CD310 in metastatic tumors, as well as an association between VEGFR3/FLT4/CD310 expression and poorer patient survival. Overall, our findings offer new insights into the contribution of VEGFR3/FLT4/CD310 inhibition to restoring a pro-inflammatory tumor myeloid compartment and suggest M-LECP cells as candidate fruquintinib targets to overcome immunosuppression in tumors.

Fruquintinib was discontinued, and the patient made a full neurological recovery. This case highlights a rare but significant toxicity of anti-vascular endothelial growth factor (VEGF) therapy in the colorectal cancer setting and underscores the importance of early radiological evaluation in suspected PRES.

P2, N=120, Recruiting, Criterium, Inc. | Not yet recruiting --> Recruiting

Notable findings include durable survival with pembrolizumab and nivolumab + ipilimumab in MSI-H/dMMR mCRC, efficacy of fruquintinib in refractory disease, and promising early outcomes with SCRT-based immunochemotherapy in LARC. Recent trials support precision oncology in CRC, highlighting durable benefits of targeted and immune therapies. However, heterogeneity in trial designs and underrepresentation of real-world populations limit generalizability.

P2, N=292, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences