Biomarker Validation for Treatment Efficacy and Recurrence Prediction in Hepatocellular Carcinoma

NCT07840092 | Recruiting

• 1 other identifier: 2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Hepatocellular carcinoma; biomarker; treatment response; recurrence; prognosis; observational study

Outcome Measures

Primary Outcomes (2)

• treatment response

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

  1 year

• Association between candidate biomarker expression/levels and recurrence/progression risk

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

  From baseline to end of follow-up

Secondary Outcomes (3)

• Progression-free survival (PFS)

  1 year

• Overall survival (OS)

  2 year

• Dynamic changes in alpha-fetoprotein (AFP)

  1 year

Study Arms (1)

No investigational

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

Interventions

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.

No investigational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study uses a multicenter, non-interventional observational design with both prospective and retrospective data and sample collection. The study does not change the patient's established diagnosis or treatment plan and does not assign investigational drugs or treatment pathways. Clinical data, imaging and pathology information, treatment outcomes, and available biospecimens are collected under a unified protocol at baseline, treatment/sample recording, efficacy and dynamic monitoring, and outcome/long-term follow-up

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, 300202, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Central Study Contacts

Yang Liu, PhD.

CONTACT

02223340123; yang_liu@tmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): October 12, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)