大多数转移性结直肠癌(mCRC)患者在标准治疗后的治疗选择有限。VEGFR-酪氨酸激酶抑制剂(TKIs)与免疫检查点抑制剂(ICIs)联合使用已证明在mCRC中具有临床活性。特别是在没有肝转移的患者中。TKIzanzalintinib(XL092)靶向VEGFR,MET和TAM激酶,参与肿瘤生长的蛋白质,血管生成,转移和免疫抑制。Zanzalintinib具有免疫调节特性,可以增强对ICIs的反应。介绍了STELLAR-303的设计,第三阶段,开放标签,随机研究评估了在非MSI-HmCRC期间/之后进展或难以治疗/不耐受的非MSI-HmCRC患者中,扎扎林替尼联合阿特珠单抗与瑞戈非尼的比较.主要终点是无肝转移患者的总生存期。临床试验注册:NCT05425940(ClinicalTrials.gov)。
转移性结直肠癌(mCRC)是已经扩散到身体其他部位的结肠癌或直肠癌,最常见的是肝脏,肺和腹部。初始治疗后mCRC恶化的患者选择有限。Zanzalintinib是一种新型的口服研究药物,可以减缓或阻止癌症的生长。它通过阻断在发育中起重要作用的某些蛋白质起作用,癌症的生长和扩散。Zanzalintinib还可能有助于提高另一类称为免疫检查点抑制剂(ICIs)的癌症药物的有效性。它通过激活患者的免疫系统来对抗癌症。这里,我们描述了STELLAR-303的设计,这是一项正在进行的研究,该研究比较了联合使用扎扎林替尼和一种名为阿特珠单抗的ICI药物与一种名为瑞戈非尼的mCRC批准治疗的效果.全球约有900名mCRC参与者将被纳入该研究。要纳入研究,参与者的mCRC必须在以前的治疗后恶化,并且必须没有高水平的微卫星不稳定性,这是一些mCRCs的特定特征。参与者将被随机给予两种治疗方法之一。该研究的主要目标是通过测量参与者在开始治疗后存活的时间长度来评估zanzalintinib联合阿特珠单抗与regorafenib的比较,特别是在没有扩散到肝脏的mCRC患者中。此外,这项研究将研究每种治疗的副作用。该研究目前正在寻找参与者。
Most patients with metastatic colorectal cancer (mCRC) have limited treatment options following standard-of-care therapy. VEGFR-tyrosine kinase inhibitors (TKIs) have demonstrated clinical activity in mCRC in combination with immune checkpoint inhibitors (ICIs), particularly in patients without liver metastases. The TKI zanzalintinib (XL092) targets VEGFR, MET and TAM kinases, proteins that are involved in tumor growth, angiogenesis, metastasis and immunosuppression. Zanzalintinib has immunomodulatory properties that may enhance response to ICIs. Presented is the design of STELLAR-303, a global, phase III, open-label, randomized
study evaluating zanzalintinib plus atezolizumab versus regorafenib in patients with non-MSI-H mCRC who progressed during/after or are refractory/intolerant to standard-of-care therapy. The primary end point is overall survival in patients without liver metastases.Clinical
Trial Registration: NCT05425940 (ClinicalTrials.gov).
Metastatic colorectal cancer (mCRC) is cancer of the colon or rectum that has spread to other parts of the body, most often to the liver, lungs and abdomen. People with mCRC that has worsened after initial treatment have limited options. Zanzalintinib is a novel oral investigational drug that can slow or stop cancer growth. It works by blocking certain proteins that play important roles in the development, growth and spread of cancer. Zanzalintinib may also help improve the effectiveness of another class of cancer drugs called immune checkpoint inhibitors (ICIs), which work by activating the patient\'s immune system to fight cancer. Here, we describe the design of STELLAR-303, an ongoing study that is comparing the effects of combining zanzalintinib and an ICI drug called atezolizumab with an approved treatment for mCRC called regorafenib. About 900 participants with mCRC will be enrolled in the
study worldwide. To be included in the study, participants must have mCRC that worsened after previous therapies and must not have a high level of microsatellite instability, which is a specific feature of some mCRCs. Participants will be randomly given one of the two treatments. The main goal of the study is to evaluate zanzalintinib plus atezolizumab compared with regorafenib by measuring the length of time participants are alive after starting treatment, specifically in patients with mCRC that has not spread to the liver. Additionally, the
study will look at the side effects with each treatment. The
study is currently seeking participants.