primary hepatocellular carcinoma with portal vein tumor thrombus
Conditions
Interventions
Experimental group:Carrelizumab combined with D-TACE and targeted therapy, this group of patients received D-TACE and intraoperative intraoperative intravenous infusion of carrelizumab 200 mg, and ora
Control group:The patients in this group were treated with 8 mgQD (body weight < 60kg) or 12 mgQD (body weight = 60kg) on the 3-7 days after D-TACE.
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients with stage C primary hepatocellular carcinoma of BCLC with portal vein thrombus; 2) Age >18 years and <75 years; 3) Child-Pugh classification of liver function A-B; 4) ECOG score 0-1, physical condition is good; 5) Expected survival time =6 months; 6) Blood, liver and kidney function meet the following conditions: a) Neutrophil count =1.0×109/L; b) Platelet count =50×109/L; c) Hemoglobin concentration =8.5g/dL; d) Serum albumin concentration =2.8g/dL; e) Less than 3 times the upper limit of normal bilirubin; f) AST and ALT are lower than 5 times of the upper limit of normal; g) Prothrombin time is not extended beyond the upper limit of normal 6 seconds; h) Creatinine less than 1.5 times the upper normal limit. 7) The patient was given carrilizumab and/or without Lunvatinib voluntarily 8) The subjects voluntarily joined the study, signed the informed consent, complied well, and cooperated with follow-up;
Exclusion criteria
Exclusion criteria: 1) Liver occupying more than 70% of liver volume; 2) Hepatocellular carcinoma invades large blood vessels except portal veins; 3) hepatocellular carcinoma with extrahepatic metastasis; 4) A history of hepatic encephalopathy, refractory ascites or gastroesophageal venous rupture bleeding; 5) Estimated survival time =6 months; 6) accompanied by other malignant tumors or had other malignant tumors within 5 years prior to enrollment; 7) severe dysfunction of heart, kidney and other organs; 8) There are contraindications for TACE treatment, such as portal shunt, detached hepatic blood flow, and obvious atherosclerosis; 9) Pregnant or lactating women or subjects who planned to have a family within two years 10) Participated in other drug clinical trials within 12 months before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Progression-Free-Survival, PFS; | — |
Countries
China
Contacts
Public ContactNIE CHUNHUI
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed