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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Objective Progression-Free Survival (PFS)
To analyse the Progression-Free Survival (PFS) of patients
Time frame: Up to approximately 1 years
Objective Secondary Clinical Endpoints - Overall Growth Phase (OS)
To analyse the Secondary Clinical Endpoints - Overall Growth Phase (OS) of patients
Time frame: Up to approximately 1 years
Objective Objective Response Rate (ORR)
To exprole the Objective Response Rate (ORR) of patients
Time frame: Up to approximately 1 years
ObjectiveDuration of Response (DOR)
To analyse the Duration of Response (DOR) of patients
Time frame: Up to approximately 1 years
Diversity analysis
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.
Time frame: 0 weeks, 12 weeks, 24 weeks and 48 weeks
Species differential analysis
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.
Time frame: 0 weeks, 12 weeks, 24 weeks and 48 weeks
Feces Metabolomics
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.
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Time frame: 0 weeks, 12 weeks, 24 weeks and 48 weeks
Serum Metabolomics
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.
Time frame: 0 weeks, 12 weeks, 24 weeks and 48 weeks