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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is a single arm, single center, prospective and open exploratory study.

About 15 patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation are expected to be enrolled.Patients will be treated with bevacizumab and FOLFOX4.Treatment was continued until disease progression, development of intolerable toxicities, death, withdrawal of consent, initiation of new antitumor therapy, whichever occurred first.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Treatments: Bevacizumab

Criteria

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.