Health Condition 1: E889- Metabolic disorder, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Aster CMI Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Adults greater than or equal to 18 years diagnosed with biopsy proven advanced or unresectable HCC. Patients with BCLC stage C or BCLC stage B Treatment-na ve for systemic therapy. Child Pugh A or B ECOG Lesser than or equal to 2. Signed informed consent.
Exclusion criteria
Exclusion criteria: Prior liver transplant. Previous systemic therapy for HCC. Significant comorbidities or active infections High risk esophageal or gastric varices Special populations, minors, pregnant mothers, neonates.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the changes in metabolomic profiles and gut microbiota composition in patients with hepatocellular carcinoma (HCC) (BCLC stage B and C) from baseline to after three cycles of immunotherapy with atezolizumab and bevacizumab.Timepoint: At Baseline and after 3 months of immunotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To correlate the changes in metabolomic & microbiota profiles with treatment outcomes, including objective response rate (ORR) & progression-free survival (PFS). 2.To identify specific metabolomic markers & microbial taxa that are predictive of a positive or negative response to immunotherapy. 3.To evaluate whether baseline microbiota & metabolomic signatures can serve as predictive biomarkers for treatment efficacy in HCC patients receiving immunotherapy. 4.To explore the association between gut microbiota diversity & shifts in specific metabolic pathways with patient prognosis & immunotherapy-related outcomes. Timepoint: At Baseline & after 3 months of immunotherapy | — |
Countries
India
Contacts
Public ContactDr Surinder Kher
Aster CMI Hospital
Outcome results
None listed