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Biomarker Validation for Treatment Efficacy and Recurrence Prediction in Hepatocellular Carcinoma

Biomarker Validation for Treatment Efficacy and Recurrence Prediction in Hepatocellular Carcinoma

Recruiting
18 years and older
All
Phase N/A

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Overview

Observational Model: Cohort Time Perspective: Other (prospective and retrospective data/sample collection) Primary Purpose: Other (biomarker validation for treatment response and recurrence prediction) Biospecimen Retention: Samples With DNA Biospecimen Description: Residual tissue, wax blocks/slides, residual puncture/surgical materials, and residual blood from routine testing; additional peripheral blood, 5-10 mL per collection, may be collected if needed after separate informed consent.

Enrollment: 500 (anticipated) Study Population: Adult patients with HCC confirmed by imaging and/or pathology at participating centers, receiving standard antitumor therapy and planned for systematic follow-up.

Sampling Method: Not specified in the protocol.

Eligibility

Inclusion Criteria:

  • 1\. Male or female aged ≥18 years. 2. HCC confirmed by imaging and/or pathology according to current Chinese guidelines.

    3\. Receiving standard antitumor therapy, such as surgery, ablation, TACE, targeted therapy, and/or immunotherapy, at participating centers and planned for systematic follow-up.

    4\. ECOG performance status 0-2; expected survival ≥3 months. 5. Child-Pugh class A or stable B; major organ function basically compensated. 6. Agrees to provide or authorize use of available clinical data, imaging/pathology information, residual tissue/wax blocks/slides from routine care, and/or residual blood samples. If additional peripheral blood collection is required, the purpose, volume, risks, sample use, and compensation arrangements will be specified in the informed consent form, and the participant must sign a separate written informed consent.

Exclusion Criteria:

  • 1\. Active malignancy at other sites, or history of other malignancy within 5 years, except cured in situ carcinoma and basal cell skin carcinoma.

    2\. Prior liver transplantation or known immunodeficiency disease. 3. Severe heart, lung, renal, or other major organ dysfunction, or uncontrolled severe infection, unable to tolerate routine antitumor therapy and follow-up.

    4\. Decompensated liver function, such as obvious refractory ascites or hepatic encephalopathy, or Child-Pugh class C.

    5\. Pregnant or breastfeeding women, or women planning pregnancy who refuse effective contraception.

    6\. Severe mental disorders or extremely poor compliance, unable to complete follow-up and specimen collection.

    7\. Other conditions considered unsuitable for inclusion by the investigator.

Study details
    Hepatocellular Carcinoma (HCC)

NCT07840092

Tianjin Medical University Cancer Institute and Hospital

26 September 2026

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