hepatocellular carcinoma
Conditions
Interventions
1: 1
Sponsors
The Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
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 2019 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. Chest, abdomen, and pelvis CT scans were performed within 3 weeks before treatment, baseline disease measurements were performed, and NGS gene testing was performed; 9. 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 x 10^9 /L; Platelet count (PLT) >= 75 x 10^9 /L; Hemoglobin (HGB) >= 9.0g /dL; (2) Liver function: Serum total bilirubin (TBIL) = 28 g/L; Alkaline phosphatase (ALP) = 50mL/min(Cockcroft Gault formula); Routine urine results showed urinary protein.2 +; For patients with urinary protein >= 2+ on routine urine tests at baseline, 24-hour urine collection, and 24-hour protein quantification should be performed.1 g; (4) Coagulation function: International standardized ratio (INR) and activated partial thrombin time (APTT) = 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. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components confirmed by histology/cytology; 2. Patients with obvious arteriovenous fistula; 3. Pregnant or lactating women; 4. Recent infections requiring antibiotic treatment; 5. There are contraindications for interventional therapy, such as severe cirrhosis, moderate or above ascites, and Child C liver function; 6. Serious dysfunction of vital organs such as the heart, brain, and lungs; 7. Uncontrolled hypertension, gastrointestinal bleeding or coagulation dysfunction, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;disease control rate, DCR;Surgical resection rate;overall survival, OS;Adverse event; | — |
Countries
China
Contacts
Public ContactJianbing Wu
The Second Affiliated Hospital of Nanchang University
Outcome results
None listed