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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date14 Aug 2024 |
一项在头颈部鳞状细胞癌受试者中评价创新联合治疗的II期平台研究
一项在既往未经治疗的复发或转移性头颈部鳞状细胞癌受试者(不考虑PD-L1表达状态)中评价创新联合治疗的II期研究
[Translation] A Phase II platform study evaluating novel combination therapy in subjects with head and neck squamous cell carcinoma
A Phase II study evaluating novel combination therapy in subjects with previously untreated recurrent or metastatic head and neck squamous cell carcinoma (regardless of PD-L1 expression status)
本研究是一项开放性、多中心、随机、概念验证、全球II期平台研究,旨在评估多种创新联合疗法对HNSCC患者的疗效和安全性。灵活的临床研究设计允许根据中期数据提前终止临床有效性有限或出现不可接受毒性的试验治疗组的研究,以及当创新联合治疗可用时,将新的试验治疗组引入平台研究,并调整试验治疗组内正在接受研究的患者亚组人群。
子研究01的队列1旨在评价创新联合治疗作为r/m HNSCC受试者一线治疗的有效性和安全性。队列1(治疗组A和治疗组B)采用随机化设计,评估domvanalimab和赛帕利单抗联合含铂双药化疗对比赛帕利单抗联合含铂双药化疗的有效性和安全性。
子研究01的队列2是一个生物标志物队列,旨在评估创新联合治疗的作用机制以及治疗的有效性和安全性。本研究计划设置队列2,具体由申办方酌情决定是否启用该队列。
[Translation] This study is an open-label, multicenter, randomized, proof-of-concept, global Phase II platform study designed to evaluate the efficacy and safety of multiple innovative combination therapies in patients with HNSCC. The flexible clinical study design allows for early termination of the study of the trial treatment group with limited clinical efficacy or unacceptable toxicity based on interim data, as well as the introduction of new trial treatment groups into the platform study when innovative combination therapies become available, and the adjustment of the patient subgroup population being studied within the trial treatment group.
Cohort 1 of Substudy 01 is designed to evaluate the efficacy and safety of innovative combination therapies as first-line treatment for subjects with r/m HNSCC. Cohort 1 (treatment groups A and B) uses a randomized design to evaluate the efficacy and safety of domvanalimab and sepalizumab combined with platinum-based doublet chemotherapy versus sepalizumab combined with platinum-based doublet chemotherapy.
Cohort 2 of Substudy 01 is a biomarker cohort designed to evaluate the mechanism of action of innovative combination therapies and the efficacy and safety of treatment. Cohort 2 is planned for this study, and the sponsor will decide whether to enable this cohort at its discretion.
一项评估安必速在中国临床实践中的安全性和有效性的前瞻性、观察性、多中心、上市后研究
[Translation] A prospective, observational, multicenter, post-marketing study to evaluate the safety and efficacy of Anbisu in clinical practice in China
评估注射用两性霉素B脂质体(商标:安必速®)在中国成人和1个月至18岁儿童患者中的有效性和安全性。
[Translation] To evaluate the efficacy and safety of liposomal amphotericin B for injection (trademark: Amphotericin B®) in Chinese adults and pediatric patients aged 1 month to 18 years.
/ Active, not recruitingPhase 4 在中国推广和实施HIV暴露前预防(PrEP):武汉和广州高危青少年PrEP示范项目
[Translation] Promoting and implementing HIV pre-exposure prophylaxis (PrEP) in China: PrEP demonstration projects for high-risk adolescents in Wuhan and Guangzhou
目标1:记录两座中国城市中3,200名高危MSM人群和大学年龄段的青年中每天一次使用PrEP的人数 。
目标2:通过对中国两座城市的3,200名高危MSM人群和大学年龄段的青年进行问卷调查,获取他们有关 HIV / STI的风险行为以及有关性行为和使用PrEP的知识,看法和做法。
目标3:获取中国两座城市3,200名MSM和大学年龄段青年梅毒和HIV感染率以及1,200名PrEP使用者中梅毒,淋病,衣原体和HIV感染率的数据。
目标4:确定6个月和12个月时1,200名使用PrEP的人的保留率,依存率和特征。
目标5:通过与选定参与者(n = 30)进行的深入访谈,评估MSM和大学年龄青年中PrEP微信小程序干预的经验。
[Translation] Objective 1: To record the number of people who use PrEP once a day among 3,200 high-risk MSM and college-age youth in two Chinese cities.
Objective 2: To obtain HIV/STI risk behaviors and knowledge, perceptions, and practices regarding sexual behaviors and PrEP use through questionnaire surveys among 3,200 high-risk MSM and college-age youth in two Chinese cities.
Objective 3: To obtain data on syphilis and HIV prevalence among 3,200 MSM and college-age youth and syphilis, gonorrhea, chlamydia, and HIV prevalence among 1,200 PrEP users in two Chinese cities.
Objective 4: To determine retention, adherence, and characteristics of 1,200 PrEP users at 6 and 12 months.
Objective 5: To evaluate the experience of the PrEP WeChat mini-program intervention among MSM and college-age youth through in-depth interviews with selected participants (n = 30).
100 Clinical Results associated with Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
0 Patents (Medical) associated with Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
100 Deals associated with Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
100 Translational Medicine associated with Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.