Wenzhe Fan, Dr.

CONTACT

Lead Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

•1. histologically or clinically confirmed primary hepatocellular carcinoma, beyond Milan criteria (single lesion \>5 cm OR ≥3 lesions with at least one ≥3 cm). At least one intrahepatic measurable lesion with tumor burden ≤50%, no distant metastasis. No prior antitumor therapy within 12 months before enrollment.
•2. underwent TIPS procedure for secondary prevention of variceal bleeding or refractory ascites. Confirmed patent TIPS at 1-month follow-up with portosystemic blood flow visible throughout the shunt and Doppler velocity \> 60 cm/s.
•3. child-Pugh class A or B.
•4. estimated survival ≥3 months.
•5. adequate organ function:Neutrophils ≥1.5 × 10⁹/L; Platelets ≥50 × 10⁹/L; Hemoglobin ≥90 g/L; Serum albumin ≥30 g/L; Bilirubin ≤50 μmol/L; AST/ALT ≤5 × upper limit of normal (ULN), ALP ≤4 × ULN; INR ≤2.3; Creatinine ≤1.5 × ULN.

•1. diffuse hepatic infiltration, unassessable lesions on imaging, or tumor burden \>50%.
•2. simultaneous portal vein branch tumor thrombus or main portal vein tumor thrombus.
•3. underwent liver transplantation or antitumor therapy after TIPS placement.
•4. contraindications to TACE (e.g., portosystemic shunt, hepatofugal blood flow, significant atherosclerosis).
•5. presence of brain metastases.
•6. Allergy to contrast agents.
•7. pregnancy, breastfeeding, or planning pregnancy within 2 years.
•8. co-infection with HIV or syphilis.
•9. concurrent other malignancy or history of other malignancy within the past 5 years.
•10. severe cardiac, renal, or other organ dysfunction.
•11. active clinically severe infection \> Grade 2 (per NCI-CTC v5.0).
•12. psychiatric/psychological conditions that may impair informed consent.
•13. participation in other drug clinical trials within 12 months prior to enrollment.

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