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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Study of Biomarkers for Predicting Treatment Efficacy in Patients With Hepatocellular Carcinoma Based on Prospective and Retrospective Clinical Samples
- ClinicalTrials.gov ID
- NCT07840092
- Acronym / sponsor ID
- 2
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Hepatocellular carcinoma; biomarker; treatment response; recurrence; prognosis; observational study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No investigational | – | Other: No investigational intervention. Participants receive standard clinical care. Clinical data, imaging/pathology information, and available biospecimens are collected for research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No investigational intervention. Participants receive standard clinical care. Clinical data, imaging/pathology information, and available biospecimens are collected for research.No investigational intervention. Participants receive standard clinical care. Clinical data, imaging/pathology information, and available biospecimens are collected for research. | Other | No investigational |
Primary outcome
treatment response
Time frame: 1 year
Correlation/association between tissue or blood biomarker results and imaging/pathology/laboratory-based treatment response
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
3 secondary outcomes
Progression-free survival (PFS)
Time frame: 1 year
Overall survival (OS)
Time frame: 2 year
Dynamic changes in alpha-fetoprotein (AFP)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Liu, PhD. (02223340123, yang_liu@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment response (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.