efficacy, safety, and immunogenicity of an oral recombinant helicobacter pylori vaccine in children in china a randomised, double-blind, placebo-controlled, phase 3 trial:口服重组幽门螺杆菌疫苗在中国儿童中的疗效、安全性及免疫原性研究:一项随机,双盲,安慰剂对照,3期试验 ...
A pivotal Phase 3 clinical trial testing a combination of Cabometyx (cabozantinib) with Tecentriq (atezolizumab) versus standard care of Nevaxar (sorafenib) in previously untreated patients with advanced hepatocellular carcinoma (HCC) — the most common type of liver cancer — has begun. The multi-...
The strength of tirzepatide is underscored by comparison with a similarly designed trial of liraglutide (3.0 mg), approved for chronic weight management. After losing an average 6.0% of baseline weight in a comparable lead-in program, participants who received liraglutide achieved an additional 6....
This international trial will be conducted at 200 sites. Pt eligibilities: (1) ≥12 years of age; (2) Stage IIc, III or IV (all M-stages) and histologically confirmed Mel, completely resected ≤12 weeks prior to randomization; (3) no prior systemic anti-cancer Rx or radiation Rx for...
aWould either of these conditions be a significant demonstration of efficacy for the agency to grant full NDA approval based on a single Phase 3 trial? 这些情况之一是否是效力的一次重大示范为了代办处能授予根据一次单阶段3试验的充分的NDA认同?[translate]...
The European Organization for Research and Treatment of Cancer (EORTC) 24954 phase 3 randomized clinical trial compared 2 schemes of combined chemotherapy for patients with resectable cancers of the hypopharynx and larynx: sequential induction chemotherapy and radiotherapy versus alternating chemoradiotherapy....
In the primary analysis of the phase 3 MAIA trial (median follow-up 28·0 months), a significant improvement in progression-free survival was observed with daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in transplantation-ineligible patients with newly diagnosed...
This trial aims to test efficacy and safety of leritrelvir monotherapy in adults with mild-to-moderate COVID-19. Methods This was a randomised, double-blind, placebo-controlled, multicentre phase 3 trial at 29 clinical sites in China. Enrolled patients were from 18 to 75 years old, ...
Phase 3 studies have been initiated in patients with newly diagnosed GBM and are currently recruiting patients. We describe the protocol for the AVAglio phase 3 registration trial, which is designed to evaluate the efficacy and safety of combining bevacizumab with standard-of-care therapy in ...
The ESCORT-NEO/NCCES01 study is a multicenter, randomized, open-label, phase 3 trial conducted across 24 centers in China, which enrolled patients with LA-ESCC. The inclusion criteria were: 1) provision of a written informed consent form and voluntary participation in the study; 2) histopathol...