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Application of Integrated Proteomic and Serum Metabolomic Analysis in Efficacy and Prognosis Assessment: A multi-omics analysis based on gut microbiota to evaluate the predictive value of microbial-derived proteins and metabolites on treatment efficacy and patient outcomes, developing non-invasive tools for treatment monitoring and prognostic prediction.
This study is a prospective, observational study based on real-world data. It prospectively and continuously collects data from patients with unresectable hepatocellular carcinoma who have received TACE combined with targeted and immunotherapy as part of their routine diagnostic and treatment procedures. Patients are grouped based on treatment efficacy, and integrated proteomic and serum metabolomic analyses are conducted on samples before and during treatment to obtain clinical evidence from the real world.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group 1 | Patients considered to have effective treatment after TACE combined with targeted immunotherapy, as assessed by mRECIST. | ||
| Observation group 2 | Patients considered to have ineffective treatment after TACE combined with targeted immunotherapy, as assessed by mRECIST. |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences in Macroproteomics and Serum Metabolomics Expression between Effective and Ineffective Treatment Groups. | Using two-dimensional liquid chromatography to separate proteins and perform data independent acquisition (DIA) for tissue and macro proteome analysis. Qualitative and quantitative analysis of DIA data was performed using data analysis software Spectronaut, and statistical algorithms were used to obtain differentially expressed proteins in HCC tissue and macro proteome between the effective and ineffective treatment groups. At the same time, non targeted metabolomics analysis methods were used to perform metabolomics analysis on serum samples from two groups of patients. | Starting from the completion of treatment and evaluation for all patients, up to 6 months |
| Model for predicting the efficacy and prognosis of advanced HCC treatment | Perform pathway and biological function enrichment analysis of differentially expressed proteins through IPA, analyze signal pathways and interaction networks of different bacterial strains through Unipept software, and perform pathway and functional analysis of differential metabolites through MetaboAnalyst to further screen important biomarkers. By using machine learning methods and combining ROC curves to construct efficacy prediction and prognosis judgment models, the optimal biomarker combination is obtained, and a prediction model is established. | Within six months after the completion of treatment and evaluation for all patients. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with unresectable hepatocellular carcinoma who have received TACE combined with targeted and immunotherapy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
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Storage of Remaining Samples: -80°C.
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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