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

NCT ID: NCT05355155

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-12-31

Brief 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.

Detailed 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

Conditions

Post-orthotopic Liver Transplantation; Hepatocellular Carcinoma Recurrent

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab combine with FOLFOX4

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.

Group Type: EXPERIMENTAL

Bevacizumab Biosimilar IBI305

Intervention Type: DRUG

Patients received bevacizumab and FOLFOX4 every two weeks

Interventions

Bevacizumab Biosimilar IBI305

Patients received bevacizumab and FOLFOX4 every two weeks

Intervention Type: DRUG

Other Intervention Names

FOLFOX4

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xuehao Wang

Head of Hepatobiliary Center；Academician of Chinese Academy of Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

xuehao wang

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Locations

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Countries

China

Central Contacts

yongxiang xia, doctor

Role: CONTACT

yx_xia@njmu.edu.cn

86-025-68303211

Facility Contacts

Xuehao Wang

Role: primary

wangxh@njmu.edu.cn

86-025-68303211

Other Identifiers

2021-SR-380

Identifier Type: -

Identifier Source: org_study_id