A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma
NCT04194775
Adenocarcinoma, Carcinoma
Coronado, California, United States
View Trial DetailsNCT Number: NCT05613621
This project will clarify the potential interaction between HBV infection and steatosis, and their impact on genetic alterations and tumor immune microenvironment.
This study is active but is not currently recruiting participants.
Notify Me20 year and older
All sexes
Observational
National Cheng-Kung University Hospital, Tainan, Taiwan
This study will start with a "training cohort" of the NTUH and NTU Cancer Center patients, consisting of 4 sub-groups: HBV (+) steatosis (+), HBV (-) steatosis (+), HBV (+) steatosis (-) and HBV (-) steatosis (-). HBV (+) is defined as either: (a) HBsAg (+) or (b) HBsAg (-) anti-HBc (+) and HBV DNA detectable in blood or tumor tissue. Steatosis is defined by histology. We will enroll 400 patients who had sufficient tissue for testing in the training cohort. The following studies will be performed: (1) NGS of targeted genes panel using the National Health Research Institutes precision medicine platform; (2) transcriptomic analysis of immune microenvironment using RNA-seq and multiplex immunofluorescence staining; (3) lipotoxic genotyping for SNPs; (4) clinical outcomes of MAFLD vs. non-MAFLD. The genetic and immunological features will be further tested by a "validation cohort", from collaborative hospitals. This project will clarify the potential interaction between HBV infection and steatosis, and their impact on genetic alterations and tumor immune microenvironment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 Years
using RNA-seq and multiplex immunofluorescence staining
Time frame: 2 years
lipotoxic genotyping for SNPs
Time frame: 2 years
clinical outcomes of MAFLD vs. non-MAFLD.
National Health Research Institutes, Taiwan
Other
Dissection of the Molecular and Immunological Interaction in Patients With Hepatocellular Carcinoma of Viral and Non-viral Etiologies
Acronym: T4222
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