Hepatocellular Carcinoma (HCC)NCT07840092
Biomarker Validation for Treatment Efficacy and Recurrence Prediction in Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma (HCC), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- No investigational intervention. Participants receive standard clinical care. Clinical data, imaging/pathology information, and available biospecimens are collected for research.
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2026to 31 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Cancer Hospital
Tianjin, 300202
Yang Liu, PhD., 02223340123, yang_liu@tmu.edu.cn
About this study
Official title: Clinical Validation Study of Biomarkers for Predicting Treatment Efficacy in Patients With Hepatocellular Carcinoma Based on Prospective and Retrospective Clinical Samples
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)
- Being tested
- No investigational intervention. Participants receive standard clinical care. Clinical data, imaging/pathology information, and available biospecimens are collected for research.
- Keywords
- Hepatocellular carcinoma; biomarker; treatment response; recurrence; prognosis; observational study
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| No investigational | Not described Receives: Other: No investigational intervention. Participants receive standard clinical care. Clinical data, imaging/pathology information, and available biospecimens are collected for research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment response
Correlation/association between tissue or blood biomarker results and imaging/pathology/laboratory-based treatment response
Measured: 1 year
Association between candidate biomarker expression/levels and recurrence/progression risk
Correlation between biomarker results and recurrence/progression events, including PFS/RFS
Measured: From baseline to end of follow-up
Secondary outcomes (3)
Progression-free survival (PFS)
Measured: 1 year
Overall survival (OS)
Measured: 2 year
Dynamic changes in alpha-fetoprotein (AFP)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start12 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840092
- Sponsor's protocol ID
- 2
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No