a Cohort Study (Gut Microbiota and HCC)
Prediction of Liver Cancer Treatment Response Based on Gut Microbiota: a Cohort Study
Prediction of Liver Cancer Treatment Response Based on Gut Microbiota: a Cohort Study
Sponsor study identifier
observational
100
0 countries
N/A
Study Start
August 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 7, 2024
Actual (reported)August 16, 2024
Actual (reported)August 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Objective Progression-Free Survival (PFS)
To analyse the Progression-Free Survival (PFS) of patients
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
Up to approximately 1 years
Objective Objective Response Rate (ORR)
To exprole the Objective Response Rate (ORR) of patients
Up to approximately 1 years
ObjectiveDuration of Response (DOR)
To analyse the Duration of Response (DOR) of patients
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.
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.
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.
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.
0 weeks, 12 weeks, 24 weeks and 48 weeks
This is a prospective, observational cohort study. Patients with advanced hepatocellular carcinoma who meet the enrollment and exclusion criteria, who are judged to be unresectable after evaluation by professional physicians, are planned to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors, and according to the number of such patients in Shenzhen Third People's Hospital in the case year, this study intends to include 100 study subjects
Collect patient feces、blood、urine、serum of patients at 0, 12, 24, and 48 weeks
Yong Xu, Dr
Secretary of the Party Committee of the Shenzhen Third People's Hospital
First Submitted
August 7, 2024
First Posted
August 16, 2024
Study Start
August 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 20, 2026
To Quantify the Impact of Addition of the GAAD Score to Imaging in Patients with Chronic Liver Disease Eligible for HCC Surveillance.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 16, 2024
Record last verified: 2024-08
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