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

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation group 1

Patients considered to have effective treatment after TACE combined with targeted immunotherapy, as assessed by mRECIST.

No interventions assigned to this group

Observation group 2

Patients considered to have ineffective treatment after TACE combined with targeted immunotherapy, as assessed by mRECIST.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Yue Han

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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NCC3651

Identifier Type: -

Identifier Source: org_study_id

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