Hepatic Chemotherapy, Hepatocellular Carcinoma, Liver Cancer
Conditions
Keywords
Advanced hepatocellular carcinoma, TACE, HAIC, system 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.
Interventions
PROCEDURETACE
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.
PROCEDUREHAIC
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
Sponsors
Chinese PLA General Hospital
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactQunfang Zhou, MD
Backup ContactFeng Duan, MD
Outcome results
None listed