Biomarker testing to predict treatment response and recurrence in liver cancer
Official title: Clinical Validation Study of Biomarkers for Predicting Treatment Efficacy in Patients With Hepatocellular Carcinoma Based on Prospective and Retrospective Clinical Samples
Run by Tianjin Medical University Cancer Institute and Hospital · NCT07840092 · Data updated 2026-11-12
This study tests biomarkers in adults with hepatocellular carcinoma to see if they can predict how well treatments work and the chance of the cancer coming back.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Tianjin) |
| Status | Recruiting |
| Started | October 12, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT07840092 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult patients with HCC confirmed by imaging or pathology, treated with standard therapies at participating centers, and scheduled for regular follow-up.
✕Probably not a fit
Patients who do not show biomarker signals related to treatment response or recurrence may derive no direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects clinical data, imaging, pathology information, and available biospecimens from adults with HCC receiving standard therapies. It includes prospective and retrospective sample collection with residual tissue, slides, and blood when available, plus optional extra blood samples after consent. No new treatments are administered as part of the study; data and biospecimens are used for biomarker validation. The goal is to identify markers that correlate with treatment response and recurrence to improve prognosis and future care. Enrolled participants are followed through routine care at participating centers in Tianjin to accrue up to 500 individuals.
Why it matters
Potential benefit: If successful, biomarkers could help clinicians tailor treatments and predict recurrence for better patient management.
How similar studies have gone: Biomarker-based predictive approaches have shown promise in liver cancer, but this study adds prospective and retrospective data from routine care to validate them in Chinese guidelines context.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Tianjin Cancer Hospital
Tianjin, China Recruiting
Study contacts
- Study coordinator: Yang Liu, PhD.
- Email: yang_liu@tmu.edu.cn
- Phone: 02223340123
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.