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

Nanjing Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: Hepatocellular Carcinoma Recurrent; Post-orthotopic Liver Transplantation

Treatments: Drug: Bevacizumab Biosimilar IBI305

Study type: Interventional

Funder types: Other

Identifiers

NCT05355155

2021-SR-380

Details and patient eligibility

About

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.

Full description

Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4：

1. Oxaliplatin: 85 mg/m2 , IV, D1，Q2W
2. Calcium leovorin: 200 mg/m2 ,IV, D1、D2，Q2W
3. Fluorouracil: 400 mg/m2 push infusion and given 600mg/m2 intravenously 22 hours later， D1、D2, Q2W

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Bevacizumab combine with FOLFOX4

Experimental group

Description:

Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4： 1. Oxaliplatin: 85 mg/m2 , IV, D1，Q2W 2. Calcium leovorin: 200 mg/m2 ,IV, D1、D2，Q2W 3. Fluorouracil: 400 mg/m2 push infusion and given 600mg/m2 intravenously 22 hours later， D1、D2, Q2W Treatment will continue until disease progression, an unacceptable toxicity, or the patient voluntarily discontinues the study, whichever comes first.

Treatment:

Drug: Bevacizumab Biosimilar IBI305