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NCT Number: NCT07840092

Biomarker Validation for Treatment Efficacy and Recurrence Prediction in Hepatocellular Carcinoma

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Male or female aged ≥18 years. 2. HCC confirmed by imaging and/or pathology according to current Chinese guidelines.
  • Receiving standard antitumor therapy, such as surgery, ablation, TACE, targeted therapy, and/or immunotherapy, at participating centers and planned for systematic follow-up.
  • 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.
  • 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.
  • Decompensated liver function, such as obvious refractory ascites or hepatic encephalopathy, or Child-Pugh class C.
  • Pregnant or breastfeeding women, or women planning pregnancy who refuse effective contraception.
  • Severe mental disorders or extremely poor compliance, unable to complete follow-up and specimen collection.
  • Other conditions considered unsuitable for inclusion by the investigator.

Treatment and study plan

No investigational intervention. Participants receive standard clinical care. Clinical data, imaging/pathology information, and available biospecimens are collected for research.

Other

No investigational intervention. Participants receive standard clinical care. Clinical data, imaging/pathology information, and available biospecimens are collected for research.

Primary outcomes

  1. treatment response

    Time frame: 1 year

    Correlation/association between tissue or blood biomarker results and imaging/pathology/laboratory-based treatment response

  2. Association between candidate biomarker expression/levels and recurrence/progression risk

    Time frame: From baseline to end of follow-up

    Correlation between biomarker results and recurrence/progression events, including PFS/RFS

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 1 year

  2. Overall survival (OS)

    Time frame: 2 year

  3. Dynamic changes in alpha-fetoprotein (AFP)

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Liu, PhD.

CONTACT

[email protected]

02223340123

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

Clinical Validation Study of Biomarkers for Predicting Treatment Efficacy in Patients With Hepatocellular Carcinoma Based on Prospective and Retrospective Clinical Samples

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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