HAIC Compared With TACE in Huge Hepatocellular Carcinoma

Recruiting now

Conditions studied: Hepatocellular Carcinoma, Hepatic Chemotherapy, Liver Cancer

In brief

This study intends to compare the efficacy of transcatheter arterial chemical embolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) for patients with intermediate-advanced huge hepatocellular carcinoma.

Key facts

Study ID

NCT06641713

Run by

Sun Yat-sen University

People needed

664

Starts

2024-10-01

Expected to finish

2025-12-30

Last updated by the study team

2025-03-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of primary HCC.
• Age between 18 and 75 years;
• The maximum tumor size ≥10 cm;
• Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
• limited metastases (≤5).
• Child-Pugh class A or B;
• Eastern Cooperative Group performance status (ECOG) score of 0-1;
• Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
• Prothrombin time ≤18s or international normalized ratio < 1.7.

You may not qualify if…

• recurrent HCC;
• Extrahepatic metastasis >5;
• Obstructive PVTT involving mesenteric vena cava (PVTT IV).
• Serious medical comorbidities.
• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• Eastern Cooperative Group performance status (ECOG) score of ≥2;
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

Where it is running

• Chinese PLA general hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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