An observational study in HCC - Hepatocellular Carcinoma, sponsored by Tongji Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by Tongji Hospital · Observational
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's planned enrollment of 120 is below the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with unresectable liver cancer (HCC) who are scheduled to receive HAIC/TACE plus immunotherapy at major hospitals in Shanghai. All participants must have preserved liver function (Child-Pugh A) and at least one measurable tumor. Key requirements include willingness to undergo tumor biopsy before treatment and provide repeated blood samples during therapy. Expected recruitment sources: 1) Liver cancer specialty clinics (majority), 2) Interventional radiology units.
Exclusion Criteria:
Objective Response Rate (ORR)
Proportion of patients achieving tumor shrinkage (≥30% diameter reduction) or complete disappearance on CT/MRI scans, evaluated by RECIST v1.1 criteria. Complete response = 0 visible tumor; Partial response = ≥30% reduction in total tumor size.
Time frame: From treatment initiation to 12 weeks after first therapy cycle.
Recurrence-Free Survival (RFS)
Time from successful tumor removal surgery to either: (a) new tumor growth on scans, or (b) death from any cause. Verified by quarterly CT/MRI + AFP testing.
Time frame: From surgery date to first recurrence or death (assessed monthly for 24 months).
Severe Treatment-Related Side Effects
Number of patients experiencing grade ≥3 adverse events (e.g., liver damage, low blood counts) confirmed by lab tests and physician evaluation, using CTCAE v5.0 grading.
Time frame: From first treatment dose to 30 days after final dose.
No study locations are listed for this record.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tongji Hospital