Clinical trial · Observational
Application of Integrated Proteomic and Serum Metabolomic Analysis in Assessing the Efficacy and Prognosis of TACE Combined With Targeted Immunotherapy in Unresectable Hepatocellular Carcinoma
NCT06540508CI-TRIAL-00079474unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Observation group 1
- description
- Patients considered to have effective treatment after TACE combined with targeted immunotherapy, as assessed by mRECIST.
- label
- Observation group 2
- description
- Patients considered to have ineffective treatment after TACE combined with targeted immunotherapy, as assessed by mRECIST.
Primary outcomes (2)
- measure
- Differences in Macroproteomics and Serum Metabolomics Expression between Effective and Ineffective Treatment Groups.
- timeFrame
- Starting from the completion of treatment and evaluation for all patients, up to 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Histologically or clinically diagnosed with hepatocellular carcinoma (HCC). * Classified as BCLC stage B/C, not suitable for surgical resection or liver transplantation. * Planned or already receiving TACE combined with tiragolumab and first-line targeted therapy for liver cancer. * Not participating in other clinical studies. * Able to obtain imaging evaluation data and other clinical records during treatment. Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC, or mixed hepatocellular-cholangiocarcinoma histology. * Tumors involving the main portal vein or inferior vena cava. * Use of antibiotics within one month before treatment. * History of other malignancies.
References
Publications (0)
Data not yet available
No reference posted for this study.