OncoMatch/Clinical Trials/NCT06632717
Hepatic Arterial Infusion Chemotherapy With Lipiodol Embolization in Advanced Hepatocellular Carcinoma
Is NCT06632717 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cisplatin and 5-fluorouracil for hepatocellular carcinoma.
Treatment: Cisplatin · 5-fluorouracil — Hepatic artery infusion chemotherapy (HAIC) is a locoregional therapy commonly used in hepatocellular carcinoma (HCC), with high response rates and minimal impairment of liver function reported. Transarterial chemoembolization (TACE) and transarterial embolization (TAE) are also commonly used in HCC, with high response rates reported yet carry risks of impairing liver function after repeated embolization with a definitive embolic agent. On the other hand, lipiodol used in TACE/TAE has transient and plastic embolization effects on the tumor in contrast to the long-lasting embolization effect of the definitive embolic agent. This study investigates whether combining HAIC with lipiodol embolization will increase efficacy with good liver function preservation.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage BCLC STAGE B, BCLC STAGE C (BCLC)
Barcelona Clinic Liver Cancer (BCLC) Stage C disease (liver confined disease or liver predominant disease, as determined by the investigator) or BCLC Stage B disease who failed standard treatment (i.e., TACE in intermediate stage HCC or systemic therapy in advanced HCC) or refused standard treatment or intolerable to standard treatment.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anticancer therapy
Exception: washout >14 days prior to first dose of study drug
Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤14 days prior to the first dose of the study drug.
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dL; ANC ≥1.0 x 10^9/L (≥ 1,000 per mm3); Platelet count ≥75 x 10^9/L (≥75,000 per mm3)
Kidney function
Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by Cockcroft-Gault formula or by 24-hour urine collection
Liver function
Serum bilirubin ≤2 x institutional ULN; AST (SGOT)/ALT (SGPT) ≤3x ULN unless active liver malignancies are present, in which case ≤5x ULN; Child-Pugh class A or B7
Adequate normal organ and marrow function as defined below: (1) Hemoglobin ≥9.0 g/dL (2) Absolute neutrophil count (ANC) ≥1.0 x 10^9/L (≥ 1,000 per mm3) (3) Platelet count ≥75 x 10^9/L (≥75,000 per mm3) (4) Serum bilirubin ≤2 x institutional upper limit of normal (ULN). (5) AST (SGOT)/ALT (SGPT) ≤3x institutional upper limit of normal unless active liver malignancies are present, in which case it must be ≤5x ULN (6) Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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