Bevacizumab Biosimilar Plus FOLFOX4 in the Treatment of Recurrent HCC After Liver Transplantation

Inclusion criteria:

• adult patients with hepatocellular carcinoma who have received liver transplantation have postoperative radiographic or pathological evidence of recurrence;
• have not received the first line of standard treatment or have received the first line of standard treatment failure;
• at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 2;
• Child-Pugh class A or B (Child-Pugh score ≤7 );
• adequate organ function;
• a predicted life expectancy of at least 3 months.

Exclusion Criteria:

• allergy to the study drugs or their expedients or severe allergy to other monoclonal antibodies;
• receipt of attenuated inactivated vaccines within 4 weeks of the start of the study or scheduled for such vaccination during the study;
• evident concern of GI bleeding (local active ulcer, Guaic test at least ++) or a history of GI bleeding within the preceding 6 months;
• uncontrolled pleural or peritoneal effusion;
• pulmonary tuberculosis, sarcoidosis, HIV infection, or active HBV or HCV infection;
• uncontrolled cardiac arrhythmia (including QTC interval ≥500 ms);
• hepatic encephalopathy;
• Known hepatocholangiocarcinoma, mixed hepatocellular and cholangiocellular carcinoma, fibrolamellar carcinoma, or a history of or concurrent cancer except cervical carcinoma in situ and cured basal cell carcinoma;
• pregnant or lactating women or women contemplating pregnancy;
• severe concomitant illness that jeopardizes patient safety or interferes with the completion of the study as deemed by the investigators;
• esophageal or gastric variceal bleeding with portal hypertension within the past 6 months.