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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From treatment initiation to 12 weeks after first therapy cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From surgery date to first recurrence or death (assessed monthly for 24 months). |
| Severe Treatment-Related Side Effects |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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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. |
| From first treatment dose to 30 days after final dose. |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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