Hepatocellular carcinoma (HCC)
Conditions
Interventions
Poppy lipiodol embolization + D-TACE embolization group:Poppy lipiodol embolization combined with D-TACE embolization
D-TACE group:D-TACE treatment
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 85 years; 2.Strictly meet the clinical diagnostic criteria of the "Standards for the Diagnosis and Treatment of Primary Liver Cancer" (2020 Edition) or diagnosed as primary hepatocellular carcinoma by histopathology or cell examination; 3.BCLC stages A2, A3, B and C (corresponding to Chinese stages Ib, IIa, IIb and IIIa); 4.The main organs are functioning normally, that is, they meet the following standards: (1)The standard of routine blood examination should meet the following standards (no blood transfusion and products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): 1)Hgb>=90 g/L; 2)ANC>=1.5.x10^9/L; 3)PLT>=40x10^9/L; (2)The biochemical inspection shall meet the following standards: 1)ALB >= 29g/L; 2)ALT and AST 45 ml/min (Cockcroft-Gault formula); 5.Confirm that there is at least one measurable HCC lesion; 6.The patient is expected to survive more than 3 months; 7.Within 7 days before the first administration of the study drug, the physical performance status (PS) score of the Eastern Cooperative Oncology Group (ECOG) is 0-2; 8.Child-Pugh liver function rating: Grade A, B (Chid-Pugh score<=7); 9.Subjects voluntarily join the study and sign an informed consent form. They have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Diffuse liver cancer; 2.Suffering from myocardial ischemia or infarction above grade II, poorly controlled arrhythmia (including QTc interval >=470ms); according to NYHA standards, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination reveals left ventricular ejection fraction ( LVEF) 1.5 or PT>ULN+4 seconds or APTT > 1.5 ULN), have bleeding tendency or are receiving thrombolytic anticoagulation therapy; 4.Pregnant or breast-feeding women; or fertile patients who are unwilling to be unable to take effective contraceptive measures; 5.Combined with HIV-infected patients; 6.Patients with liver resection, liver transplantation, chemotherapy, interventional therapy, and other malignant tumors; 7.Patients with contraindications to TACE and chemotherapy drugs; 8.Patients with poor compliance such as floating population; 9.Are currently participating in or have previously participated in experimental drug research, or have used experimental devices within 4 weeks before the first administration of the research drug; 10.Have a mental illness or a history of psychotropic drug abuse; 11.There are more than 5 lesions evaluated by imaging or HCC lesions account for >=70% of the liver volume; 12.People who are allergic to iodine contrast agent/gadolinium contrast agent; 13.Patients considered by the investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;overall survival;therapeutic response rate;time to progression;TACE treatment times;changes in tumor markers;changes in liver function;recurrence rate of liver cancer; | — |
Countries
China
Contacts
Public ContactZheng Xin
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed