Hepatic Arterial Infusion Chemotherapy in Combination With Atezolizumab and Bevacizumab for Second-line Treatment of Patients With Recurrent Liver Cancer After Liver Transplantation
Recurrent Liver Cancer After Liver Transplantation
About this trial
This is an interventional treatment trial for Recurrent Liver Cancer After Liver Transplantation focused on measuring Atezolizumab, Bevacizumab, Hepatic arterial infusion chemotherapy
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old, ≤75 years old, gender unlimited; hepatocellular carcinoma confirmed by pathology after liver transplantation; CT and/or MRI confirmed tumor recurrence or metastasis, intrahepatic recurrence and extrahepatic metastasis were not suitable for surgical resection; There is at least one measurable recurrent or metastatic tumor lesion; The expected survival time is more than 3 months; Child-Pugh grade A and B (≤7 points); Function of other vital organs: absolute neutrophil count ≥1.5×10E9/L; Platelet ≥50×10 e9 / L; Hemoglobin ≥9 g/dL; Serum albumin ≥2.8g/dL; Thyroid stimulating hormone (TSH)≤1 ULN(if TSH is abnormal, both T3 and T4 levels should be checked. If the levels of T3 and T4 were normal, the patients could be enrolled); Bilirubin ≤ 1.5x ULN; ALT and AST≤3 times ULN; Serum creatinine ≤1.5 ULN; ECOG scored 0-2 points; The patient fully understands and voluntarily signs the informed consent, and is willing and able to comply with the requirements of visit, treatment plan, laboratory examination and other requirements of the study schedule. Exclusion Criteria: Positive expression of PD-L1 in immunohistochemical liver biopsy (parenchymal or non-parenchymal cells of liver); Allergic to bevacizumab and Atezolizumab; ≥ grade II myocardial ischemia or myocardial infarction; The hypertensive drugs cannot be controlled to the normal level (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg); Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg <2g/L), a history of gastrointestinal bleeding within 6 months; Patients with high risk of bleeding or receiving thrombolytic or anticoagulant treatment; Autoimmune diseases include systemic lupus erythematosus, rheumatoid arthritis, psoriasis, etc.; The primary liver disease of liver transplantation was autoimmune hepatitis, primary biliary cirrhosis, or primary sclerosing cholangitis; interstitial pneumonia and other lung diseases, poor lung function; Participate in clinical trials of other experimental drugs within 4 weeks; infections requiring systemic treatment; human immunodeficiency virus (HIV) positive infection; Other factors that may affect safety or compliance; During treatment of acute rejection or within 1 month after treatment; Poor compliance.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumab
Hepatic arterial infusion chemotherapy: percutaneous introduction of a standard hepatic arterial catheter through the femoral artery. FOLFOX was sequentially transfused by a fixed catheter. Drugs:FOLFOX regimen: oxaliplatin, calcium folinate, and 5-FU. Atezolizumab: About 3 to 7 days after HAIC treatment, when liver function is stable (TBILI<2 times the upper limit of normal), Atezolizumab therapy can be started. The dosage was 1200mg and was given intravenously for at least 1 hour, once every 3 weeks. The longest course of treatment is 24 months. Bevacizumab: About 3 to 7 days after HAIC treatment, when liver function is stable (TBILI<2 times the upper limit of normal), bevacizumab therapy can be started. The dosage was 15mg/kg and was given intravenously for no less than 1 hour, once every 3 weeks. The longest course of treatment is 24 months.