Prediction of Liver Cancer Treatment Response Based on Gut Microbiota: a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Objective Secondary Clinical Endpoints - Overall Growth Phase (OS)
研究概览
简要总结
To analyze the predictive role of intestinal microbiota in tyrosine kinase inhibitors (TKIs) combined with immunotherapy response in patients with intermediate and advanced liver cancer.
详细描述
This is a prospective, observational cohort study. Patients with intermediate and advanced hepatocellular carcinoma who meet the enrollment and exclusion criteria are judged to be unresectable after evaluation by professional physicians, and are intended to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors. During the treatment according to clinical needs, stool and blood samples were taken regularly, and the treatment response of patients was judged according to RECIST V1.1 criteria, and the common adverse reactions during treatment were evaluated by the CTCAE5.0 grading system, and the relationship between intestinal microbiota and liver cancer treatment response was analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old, gender unlimited
- •Diagnosed as HCC through pathological or clinical examination
- •BCLC Phase B or C
- •Previously without systematic treatment
- •Irremovable
- •Intended to receive targeted anti-angiogenic drugs combined with immune checkpoint inhibitors for treatment
- •≥ 1 measurable lesion (RECIST V1.1)
- •ECOG PS 0-1
- •The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
排除标准
- •Received attenuated live vaccine within 4 weeks prior to enrollment or planned during the study period
- •Active, known or suspected autoimmune diseases
- •Known history of primary immunodeficiency
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- •Pregnant or lactating female patients
- •Uncontrolled concurrent diseases
- •Currently conducting clinical trials for other drugs
- •Other patients deemed unsuitable for inclusion by researchers
结局指标
主要结局
Objective Secondary Clinical Endpoints - Overall Growth Phase (OS)
时间窗: Up to approximately 1 years
To analyse the Secondary Clinical Endpoints - Overall Growth Phase (OS) of patients
Serum Metabolomics
时间窗: 0 weeks, 12 weeks, 24 weeks and 48 weeks
Changes of metabolites in serum measured by metabolomic mass spectrometry, unsupervised PCA (principal component analysis) was performed by statistics function prcomp, identified metabolites were annotated using KEGG Compound database.
Objective Progression-Free Survival (PFS)
时间窗: Up to approximately 1 years
To analyse the Progression-Free Survival (PFS) of patients
Species differential analysis
时间窗: 0 weeks, 12 weeks, 24 weeks and 48 weeks
We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the PCA、PCoA and NMDS analysis will be used to assess the similarities and differences in species composition.
Objective Objective Response Rate (ORR)
时间窗: Up to approximately 1 years
To exprole the Objective Response Rate (ORR) of patients
ObjectiveDuration of Response (DOR)
时间窗: Up to approximately 1 years
To analyse the Duration of Response (DOR) of patients
Diversity analysis
时间窗: 0 weeks, 12 weeks, 24 weeks and 48 weeks
We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity.
Feces Metabolomics
时间窗: 0 weeks, 12 weeks, 24 weeks and 48 weeks
Changes of metabolites in feces measured by metabolomic mass spectrometry, unsupervised PCA (principal component analysis) was performed by statistics function prcomp, identified metabolites were annotated using KEGG Compound database.
次要结局
未报告次要终点
研究者
Xu Yong, MD
Secretary of the Party Committee
Shenzhen Third People's Hospital