Clinical trial NCT06540508: Application of Integrated Proteomic and Serum Metabolomic Analysis in Assessing the Efficacy and Prognosis of TACE Combined With Targeted Immunotherapy in Unresectable Hepatocellular Carcinoma
Official 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hepatocellular Carcinoma
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unresectable hepatocellular carcinoma who have received TACE combined with targeted and immunotherapy

Brief 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.

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.

Primary outcomes:
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
measure: Model for predicting the efficacy and prognosis of advanced HCC treatment
timeFrame: Within six months after the completion of treatment and evaluation for all patients.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: