HAIC Compared With TACE in Huge Hepatocellular Carcinoma

Recruiting

• Conditions: Hepatocellular Carcinoma; Hepatic Chemotherapy; Liver Cancer

• Registration Number: NCT06641713
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Transcatheter arterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) are effective and safe for hepatocellular carcinoma (HCC). For huge HCC (≥10 cm), the prognosis of this high tumor-burden subtype usually indicates poor outcome and big challenge. TACE is difficult to completely embolize all tumor arteries, so patients have limited benefit from pure hepatic artery embolization. At the same time, excessive embolization will lead to massive tumor necrosis in a short time, and inflammatory necrosis factor will enter the blood, resulting in systemic inflammatory response. HAIC have showed good efficacy especially for advanced huge HCC (≥10 cm) complicated with portal vein tumor thrombus and arteriovenous fistula, and HAIC therapy can be performed with better and higher tumor control.

Study Timeline

• Study Start: 2024-10-01
• Study First Submitted: 2024-10-12
• Study First Submitted QC: 2024-10-12
• Study First Posted: 2024-10-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 664

Inclusion Criteria

1. Clinical diagnosis of primary HCC.
2. Age between 18 and 75 years;
3. The maximum tumor size ≥10 cm;
4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
5. limited metastases (≤5).
6. Child-Pugh class A or B;
7. Eastern Cooperative Group performance status (ECOG) score of 0-1;
8. 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
9. Prothrombin time ≤18s or international normalized ratio < 1.7.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate	6 months	ORR, as determined based on tumor response according to mRECIST, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.

Secondary Outcome Measures

Name	Time	Method
Progression-Free-Survival	12 months	Progression was defined as progressive disease by independent radiologic review
Overall survival	24 months	OS is the length of time from the date of inclusion until death from any cause.

Trial Locations

Locations (1)

Chinese PLA general hospital; 🇨🇳 Beijing, Beijing, China