Clinical trial NCT06641713: HAIC Compared With TACE in Huge Hepatocellular Carcinoma
Official title: Hepatic Arterial Infusion Chemotherapy Compared With Transcatheter Arterial Chemoembolizationin Intermediate-advanced Huge Hepatocellular Carcinoma: a Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Hepatic Chemotherapy
Liver Cancer
Keywords: Advanced hepatocellular carcinoma
TACE
HAIC
system therapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2024-10-15
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is a multicenter, observational real-world study to compare the efficacy of HAIC with TACE in advancedhuge hepatocellular carcinoma. This study focused on the management of locoregional therapy . This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC and TACE in huge HCC therapy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate
timeFrame: 6 months
Secondary outcomes:
measure: Progression-Free-Survival
timeFrame: 12 months
measure: Overall survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA general hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Feng Duan, MD
role: STUDY_DIRECTOR
References: