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NCT07840092From ClinicalTrials.govRecruiting

Biomarker Validation for Treatment Efficacy and Recurrence Prediction in Hepatocellular Carcinoma

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

  • Hepatocellular Carcinoma (HCC)

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Enrolment target
500
Started
12 October 2026
Main results due
31 December 2027
Study sites
1
Registry updated
24 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Tianjin Cancer Hospital

    Tianjin, China

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07840092. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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