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Trial Title:
Application of Integrated Proteomic and Serum Metabolomic Analysis in Assessing the Efficacy and Prognosis of TACE Combined With Targeted Immunotherapy in Unresectable Hepatocellular Carcinoma
NCT ID:
NCT06540508
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Observational [Patient Registry]
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Prospective
Summary:
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.
Criteria for eligibility:
Study pop:
Patients with unresectable hepatocellular carcinoma who have received TACE combined with
targeted and immunotherapy
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Start date:
February 1, 2023
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06540508
