NCT07117279Not yet recruiting
A Prospective Observational Cohort Study on Dynamic CD8+ T-cell Profiling and Multi-omics Biomarkers for Predicting Conversion Therapy Response in Unresectable Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 12 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to identify early predictors for successful liver cancer treatment conversion. We will track changes in immune cells (CD8+ T-cells) in the blood during chemotherapy infusion (HAIC/TACE) combined with targeted-immunotherapy for 120 patients with unresectable liver cancer. By analyzing blood and tissue samples at multiple timepoints using advanced cell profiling and multi-omics sequencing, we seek to: Determine if early immune cell changes predict tumor shrinkage; Identify tissue biomarkers linked to longer recurrence-free survival; Build a personalized prediction model for treatment outcomes.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 5 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Tongji Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07117279
What you commit to
- Study type: Observational
- Planned participants: 120
- From 1 Sept 2025 to the primary completion date, 31 Aug 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic HCC therapy within 6 months
Other illness
- Main portal vein tumor thrombosis (VP4)
- Active autoimmune disease requiring immunosuppression
- HIV/HBV/HCV with uncontrolled viral replication
Other
- Pregnancy or refusal of contraception
Who the study is looking for
- Adults (18-75 years) with histologically confirmed HCC
- At least one measurable lesion ≥10 mm
- Planned HAIC/TACE + immunotherapy regimen
- Child-Pugh class A liver function
- ECOG 0-1
- Signed informed consent
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.