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Recruiting Observational

HAIC Compared With TACE in Huge Hepatocellular Carcinoma

NCT06641713 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-10-01
Last updated
2025-03-26

Condition(s) studied

Hepatocellular CarcinomaHepatic ChemotherapyLiver Cancer

Investigational drug(s) / intervention(s)

TACEHAIC

TACE: TACE was carried out under the guidance of digital subtraction angiography, and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The emulsion of the selected drug and the embolization agents was therefore injected infused into tumor-feeding arteries via the selective microcatheter. A final arteriography confirmed the success of the procedure. The endpoint of the TACE procedure was reached when there was no flow in the tumor-feeding vessels.

HAIC: HAIC was carried out under the guidance of digital subtraction angiography, 990and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1, and 400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2. Hepatic arterial infusion chemotherapy administration of oxaliplatin, fluorouracil, and leucovorin via the tumor feeding arteries every 4 weeks

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Chinese PLA general hospital Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06641713 on ClinicalTrials.gov ↗ ← All trials in China