advanced hepatocellular carcinoma with major vascular invasion
Conditions
Interventions
TACE/HAIC+TKI group:NA
TACE/HAIC +TKIs+ PD-1 group:NA
TACE/HAIC +TKIs+ PD-1+radiotherypy group:NA
Sponsors
Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Has a diagnosis of HCC confirmed by radiology, histology, or cytology; 2.Has repeated measurable intrahepatic lesions; 3.age between 18 and 75 years; 4.China Liver Cancer Staging (CNLC) stage ?a with the presence of macrovascular invasion; 5.Child-Pugh A or B liver function; 6.Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 7.For normal function of major organs, the following criteria should be met: a. Adequate bone marrow function, defined as: Absolute neutrophil count (white blood cell count >3?10^9/L, ANC =1.5 x 10^9 /L); Hemoglobin (Hb =8.5 g/dL) ; Platelet (PLT = 75 x 10^9/L) b. Adequate liver function, defined as: Albumin = 2.8 g/dL, ilirubin=3.0mg/dL,Aspartate aminotransferase (AST), alkaline phosphatase(ALP) and alanine aminotransferase (ALT) were = 5 times the upper limit of normal (ULN) c. Adequate coagulation function, defined as: International Normalized Ratio (INR) of 2.3 or less d. Adequate renal function, defined as: creatinine clearance >40mL/min e. Adequate pancreatic function, defined as: amylase and lipase = 1.5 times ULN; 8.Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy); 9.Witten informed consent
Exclusion criteria
Exclusion criteria: 1. Extrahepatic metastasis 2. Diffuse liver cancer 3. Patients who have received targeted drugs and immune checkpoint inhibitors in the past 4. Hypersensitivity to lenvatinib or PD-1 inhibitor components 5. History of liver resection, liver transplantation, interventional therapy, and other malignant tumors 6. Patients with active infection 7. With contraindications to radiotherapy 8. incomplete medical data 9. loss to follow-up 10. Those deemed unsuitable for inclusion by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Objective remission rate;Disease control rate;Duration of Response;Adverse event;Time to progression; | — |
Countries
China
Contacts
Public ContactWang Zusen
Affiliated Hospital of Qingdao University
Outcome results
None listed