未经证实:单纯放化疗是局部晚期肛门鳞状细胞癌(SCAC)的标准治疗方法。然而,高达50%的患者将经历复发;因此,需要新的治疗方法来改善预后.修饰多西他赛,顺铂和5-氟尿嘧啶(mDCF)是一线转移性SCAC的治疗选择,在表位-HPV01和-02试验(NCT01845779和NCT02402842)中显示出功效。mDCF治疗也在抗肿瘤免疫的调节中发挥作用,提示它可能是SCAC患者免疫治疗的良好组合伙伴。抗程序性死亡蛋白-1(PD-1)免疫疗法已被证明对转移性SCAC有效。因此,我们设计了INTERRACT-ION研究来评估mDCF与ezabenlimab(BI754091)的组合,抗PD-1抗体,然后是放化疗,在III期SCAC患者中。
未经批准:交互离子是一个关键的,开放标签,初治III期SCAC患者的单臂II期研究。患者将每2周接受mDCF诱导治疗(第1天多西他赛40mg/m2和顺铂40mg/m2,5-氟尿嘧啶1200mg/m2/天,共2天),共4个周期,每3周接受ezabenlimab(240mg静脉内给予),共3个周期。在2个月没有疾病进展的情况下,将给予两个额外的mDCF周期和一个额外的ezabenlimab周期。具有放射学客观反应的患者,然后,病理完全/接近完全反应和生物完全反应将接受调强放疗和同步化疗的相关淋巴结放疗,其次是ezabenlimab单独七个周期。所有其他患者将接受标准放化疗。主要终点是mDCF加ezabenlimab第一个周期后10个月的临床完全缓解率。主要次要终点是诱导治疗后的主要病理反应和生物学完全反应。还将在肿瘤组织和外周血中进行广泛的辅助生物标志物研究。
UNASSIGNED:在化疗中加入免疫治疗是转移性肛门癌的一个活跃领域。这项关键研究将在本地先进的环境中评估这种组合。辅助生物标志物研究将有助于理解对治疗的反应或抗性的预测因子。
UNASSIGNED:https://clinicaltrials.gov/ct2/show/NCT04719988,标识符NCT04719988。
UNASSIGNED: Chemoradiotherapy alone is the standard treatment for locally advanced squamous cell anal carcinoma (SCAC). However, up to 50% of patients will experience recurrence; thus, there is a need for new treatments to improve outcomes. Modified docetaxel, cisplatin and 5-fluorouracil (mDCF) is a treatment option for first-line metastatic SCAC, having shown efficacy in the Epitopes-HPV01 and -02 trials (NCT01845779 and NCT02402842). mDCF treatment also plays a role in the modulation of anti-tumor immunity, suggesting it may be a good combination partner for immunotherapy in patients with SCAC. Anti-programmed death protein-1 (PD-1) immunotherapy has been shown to be effective in metastatic SCAC. We therefore designed the INTERACT-ION study to assess the combination of mDCF with
ezabenlimab (BI 754091), an anti-PD-1 antibody, followed by chemoradiotherapy, in patients with Stage III SCAC.
UNASSIGNED: INTERACT-ION is a pivotal, open-label, single-arm phase II study in patients with treatment-naïve Stage III SCAC. Patients will receive induction treatment with mDCF (docetaxel 40 mg/m2 and cisplatin 40 mg/m2 on Day 1, 5-fluorouracil 1200 mg/m2/day for 2 days) every 2 weeks for 4 cycles and
ezabenlimab (240 mg given intravenously) every 3 weeks for 3 cycles. In the absence of disease progression at 2 months, two additional cycles of mDCF and one additional cycle of
ezabenlimab will be administered. Patients with radiological objective response, pathological complete/near-complete response and biological complete response will then receive an involved-node radiotherapy with intensity-modulated radiation therapy and concurrent chemotherapy, followed by
ezabenlimab alone for seven cycles. All other patients will receive standard chemoradiotherapy. The primary endpoint is the clinical complete response rate 10 months after the first cycle of mDCF plus
ezabenlimab. Major secondary endpoints are major pathological response and biological complete response after induction treatment. An extensive ancillary biomarker study in tumor tissue and peripheral blood will also be conducted.
UNASSIGNED: The addition of immunotherapy to chemotherapy is an area of active interest in metastatic anal cancer. This pivotal study will evaluate this combination in the locally advanced setting. Ancillary biomarker studies will contribute to the understanding of predictors of response or resistance to treatment.
UNASSIGNED: https://clinicaltrials.gov/ct2/show/NCT04719988, identifier NCT04719988.