primary liver cancer
Conditions
Interventions
TACE/HAIC combined with bevacizumab and sintilimab:TACE/HAIC combined with bevacizumab and sintilimab
Sponsors
The Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1: Patients with hepatocellular carcinoma confirmed by histology/cytology or cirrhosis should meet the clinical diagnostic criteria for primary liver cancer in the 2022 edition of The Chinese Code for the Diagnosis and Treatment of Primary Liver Cancer. 2: Be at least 18 years old. 3: ECOG physical status score 0 or 1 4: Barcelona Clinic Liver Cancer (BCLC) stage C.Stage B is not suitable for radical surgery and/or topical treatment. 5: No systemic antitumor therapy for hepatocellular carcinoma was received before the first administration. 6: According to RECIST V1.1, there should be at least one measurable lesion, or a measurable lesion with clear progression after local treatment (based on RECIST V1.1). 7: Child-Pugh grade A or B. 8: Have sufficient organ and bone marrow functions, and the laboratory test values within 7 days before enrollment meet the following requirements: 1) Blood routine examination: Absolute neutrophil count (ANC) = 1.5×109 /L,Platelet count (PLT) =75×109 /L,Hemoglobin (HGB) = 9.0g /dL;2) Liver function:Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =5×ULN,Serum total bilirubin (TBIL) =2× upper limit of normal value (ULN),Serum albumin =28 g/L,Alkaline phosphatase (ALP) =5×ULN;3) Renal function: Serum creatinine (Cr) = 1.5×ULN or clearance of creatinine (CCr) = 50mL/min(Cockcroft Gault formula),urine routine results showed that urine protein was less than 2+,for patients with urinary protein =2+ on routine urine tests at baseline, 24-hour urine collection and 24-hour protein quantification should be < 1g;4) Coagulation function: International standardized ratio (INR) and activated partial thrombin time (APTT) =1.5 TIMES ULN. 9: Expected survival time =12 weeks. 10: Sign written informed consent and be able to comply with the visit and related procedures stipulated in the program.
Exclusion criteria
Exclusion criteria: 1: There are contraindications for interventional therapy, such as severe liver cirrhosis, moderate or above ascites, and Child-Pugh C grade of liver function. 2: People who need antibiotic treatment for recent infection. 3: Serious dysfunction of important organs such as heart, brain and lung. 4: Uncontrollable hypertension, gastrointestinal bleeding or coagulation dysfunction. 5: Pregnant or lactating women.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Intrahepatic progression-free survival;disease control rate;urgical resection rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;objective response rate; | — |
Countries
China
Contacts
Public ContactJianbing Wu
The Second Affiliated Hospital of Nanchang University
Outcome results
None listed