Hepatocellular Carcinoma
Conditions
Interventions
Hepatic arterial infusion chemotherapy:high-dose chemotherapy (oxaliplatin, leucovorin, and fluorouracil) was continuously perfused through the hepatic artery
Transcatheter arterial chemoembolization:A mixture of iodized oil and chemotherapeutic agents was injected through the hepatic artery
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Ages 18-75 years, male or female; 2. ECOG PS score 3) distributed in the left lobe and right lobe of the liver, and the maximum diameter of the lesions was more than 4 cm (beyond the up to 7 standard). 5. The case could not be resected according to the expert group of liver surgery; 6. No contraindications for HAIC or TACE treatment; 7. Newly treated patients with at least one measurable intrahepatic lesion (Modified RECIST standard 27); 8. No cirrhosis or Child-Pugh class A cirrhosis, no ascites, and no obvious atrophy of the liver; 9. No liver protection and support treatment was performed within 2 weeks prior to enrollment, and the following conditions were met: Neutrophils >= 1500/µL; Platelet count >= 60,000/µL; Hemoglobin > 8.5 g/dL; Plasma albumin > 3.0 g/dL; Total bilirubin < 30mmol/L; ALT and AST below 5 times of the normal upper limit; INR < 1.7 or PT extension not exceeding 4 seconds; Serum creatinine is less than 1.5 times of the normal upper limit. 10. The patient is aware of the condition and signs a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Have received any previous antitumor therapy for liver cancer (excluding Chinese herbal medicine or Chinese herbal preparations); 2. Combined with tumor thrombus of main portal vein or diffuse tumor thrombus in the left and right branches, or inferior vena cava tumor thrombus, or tumor invasion of bile duct or bile duct tumor thrombus formation; 3. Diffuse liver cancer; 4. Contrast agent allergy; 5. Combined history of heart disease or uncontrolled hypertension (> 150/100mmhg); 6. Patients with thrombotic diseases or history of gastrointestinal bleeding within 6 months; 7. Patients with active infections other than HBV/HCV (above level 2 as defined in NCI CTC AE Version 5.0) or other severe concomitant diseases, unable to tolerate treatment; 8. History of other malignant tumors; 9. Related drug allergy history; 10. History of organ transplantation; 11. Pregnant or lactating women; 12. Patients with autoimmune diseases or other reasons requiring long-term use of glucocorticoids; 13. Other factors that may affect patient enrollment and evaluation results; 14. The investigator assessed poor patient compliance and was unable to ensure that patients were treated according to the study protocol and followed up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Time to progression;objective response rate;disease control rate;time to progression;duration of response;surgical resection rate;pathological remission rate;safety and tolerability; | — |
Countries
China
Contacts
Public ContactMin-Shan Chen
Sun Yat-Sen University Cancer Center
Outcome results
None listed