Hepatocellular carcinoma
Conditions
Interventions
Experimental group:Donafenib, Tislelizumab combined with hepatic arterial infusion chemotherapy (HAIC).
Sponsors
Maoming People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this study: 1.Patients voluntarily join this study and sign the informed consent form. 2.Aged 18 years >=and =10 mm or the short diameter of enlarged lymph nodes should be >=5 mm.) 5.Child-Pugh score =12 weeks. 8.The main organ functions meet the following requirements (no blood components, cell growth factors or other corrective treatment drugs are allowed within 14 days before the first medication use): (1)Blood routine examination must meet the following criteria: A. Absolute neutrophil count (ANC) >=3×10?/L; B. Platelet (PLT) >=80×10?/L; C. Hemoglobin >=90 g/L; (2)Blood biochemical examination must meet the following requirements: A. Serum albumin (ALB) >=28 g/L; B. Aspartate aminotransferase (AST) <=3×ULN; C. Alanine aminotransferase (ALT) <=3×ULN; D. Alkaline phosphatase (ALP) <=2.5×ULN; E. Total bilirubin (TBil) <=1.5×ULN; F. Serum creatinine (Cr) <=1.5×ULN; (3)Thyroid-stimulating hormone (TSH) <=1×ULN (if abnormal, FT3 and FT4 levels should also be examined simultaneously. If FT3 and FT4 levels are normal, the patient can be enrolled). (4)International normalized ratio (INR) <=2.3 or prothrombin time (PT) exceeds the normal control range by <=6 seconds, and anticoagulation therapy has not been carried out.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following conditions must be excluded from this study: 1. Have received local liver treatment for HCC. 2. Patients with any active autoimmune disease or a history of autoimmune disease. 3. Patients who are currently using immunosuppressants or systemic hormone therapy for immunosuppressive purposes and are still continuing to use them within 2 weeks before enrollment. 4. Currently suffering from interstitial pneumonia or interstitial lung disease, or having a history of interstitial pneumonia or interstitial lung disease that required steroid treatment in the past; active tuberculosis. 5. Have had a severe allergic reaction to other monoclonal antibodies. 6. Known history of central nervous system metastasis or hepatic encephalopathy. 7. Have a history of organ transplantation. 8. Diffuse changes in intrahepatic tumor lesions. 9. Blood pressure cannot be reduced to the normal range despite regular antihypertensive treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg). 10. Coronary heart disease or arrhythmia of grade >= II (including QTc interval prolongation: > 450 ms in males, > 470 ms in females). 11. Symptomatic congestive heart failure (New York Heart Association Class II - IV) or symptomatic or poorly controlled arrhythmia. 12. Coagulation dysfunction (INR > 1.5 ULN, APTT > 1.5 ULN) with a tendency to bleed. 13. Arterial/venous thrombotic events within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism. 14. Urine routine shows urine protein >= ++ and 24-hour urine protein is confirmed to be > 1.0 g. 15. Active infection requiring treatment or use of systemic anti-infective drugs within 7 days before the first dose. 16. Patients with congenital or acquired immune deficiency (such as HIV-infected individuals). 17. Coinfection with hepatitis B and hepatitis C. 18. Patients who have had other malignancies within the past 3 years or at the same time (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ). 19. Pregnant or breastfeeding women, or women of childbearing age who are unwilling to take contraceptive measures. 20. In the opinion of the investigator, the patient has other factors that may affect the study results or lead to the premature termination of this study, such as alcohol abuse, drug abuse, other serious diseases (including mental illnesses) requiring combination therapy, significant laboratory abnormalities, accompanied by family or social factors that may affect the patient's safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Time to Progression;Time to Response;Objective Response Rate;Disease Control Rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactWanzhen Li
Maoming People's Hospital
Outcome results
None listed