Application of Integrated Proteomic and Serum Metabolomic Analysis in Assessing the Efficacy and Prognosis of TACE Combined With Targeted Immunotherapy in Unresectable Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- Differences in Macroproteomics and Serum Metabolomics Expression between Effective and Ineffective Treatment Groups. [Time frame: 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 [Time frame: Within six months after the completion of treatment and evaluation for all patients.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT06540508 · NCC3651