YIV-906或安慰剂联合索拉非尼 (Nexavar®)治疗HBV感染相关晚期肝细胞肝癌患者随机双盲对照II期临床研究
[Translation] A randomized, double-blind, controlled phase II clinical study of YIV-906 or placebo combined with sorafenib (Nexavar®) in patients with HBV infection-related advanced hepatocellular carcinoma
主要目标:临床试验每组的无进展生存期(PFS)
次要目标:临床试验每组的至肿瘤进展时间(TTP);临床试验每组的客观缓解率 (ORR); 临床试验每组的疾病控制率 (DCR);临床试验每组的总生存期(OS);根据不良事件的发生率和严重程度评估YIV-906联合索拉非尼组合的安全性和耐受性;临床试验每组中的生活质量 (QoL) 变化;确定YIV-906对于索拉非尼药代动力学(PK)的影响。
探索性目标:为了研究YIV-906联合索拉非尼在患者中的生物学效应,为肝癌的早期检测和精确治疗以及预后分析奠定基础,本研究将对一系列生物标志物进行分析,其中包括:AFP、AST、ALT、细胞因子、趋化因子、HBV血清学标志物、HBV病毒载量、循环肿瘤DNA以及血清代谢组学;分析上述可溶性生物标志物结果与临床治疗终点的相关性;分析可溶性生物标志物之间的相关性;比较两组患者体内的肠道和口腔有益和致病菌群组成,包括治疗前和治疗后的对比。
[Translation] Primary objective: Progression-free survival (PFS) in each arm of the clinical trial
Secondary objectives: Time to tumor progression (TTP) for each arm of the clinical trial; Objective response rate (ORR) for each arm of the clinical trial; Disease control rate (DCR) for each arm of the clinical trial; Overall survival ( OS); assessment of safety and tolerability of YIV-906 in combination with sorafenib based on incidence and severity of adverse events; change in quality of life (QoL) in each arm of the clinical trial; determination of the effect of YIV-906 on Sorafenib Effects of fenib pharmacokinetics (PK).
Exploratory goal: In order to study the biological effect of YIV-906 combined with sorafenib in patients, to lay the foundation for early detection and precise treatment of liver cancer and prognosis analysis, this study will analyze a series of biomarkers, including : AFP, AST, ALT, cytokines, chemokines, HBV serological markers, HBV viral load, circulating tumor DNA and serum metabolomics; analysis of the correlation between the results of the above soluble biomarkers and clinical treatment endpoints; analysis of Correlations between soluble biomarkers; gut and oral beneficial and pathogenic microbiota compositions were compared between the two groups, including pre- and post-treatment comparisons.
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