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

NCT05355155 | Unknown Phase 2

• 1 other identifier: 2021-SR-380
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-orthotopic Liver Transplantation; Hepatocellular Carcinoma Recurrent

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) ,Based on RECIST 1.1

  ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator analysis. Responses (PR or CR) were confirmed no less than 4 weeks after the initial response. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is \<10 millimeter \[mm\] if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the long diameter (LD) (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.

  From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years )

Secondary Outcomes (7)

• Progression-free Survival (PFS), Based on RECIST 1.1 and mRECIST

  From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) (up to approximately 2 years )

• Disease Control Rate (DCR) ,Based on RECIST 1.1 and mRECIST

  Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit(up to approximately 2 years)

• Duration of Response (DOR) ,Based on RECIST 1.1 and mRECIST

  DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST 1.1 and mRECIST assessed by investigator analysis.

• Overall Survival (OS)

  From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )

• Time-to Response (TTR) Based on RECIST1.1 and mRECIST

  From date of first dose of study drug until CR or PR (up to approximately 2 years

Study Arms (1)

Bevacizumab combine with FOLFOX4

EXPERIMENTAL

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.

Drug: Bevacizumab Biosimilar IBI305

Interventions

Bevacizumab Biosimilar IBI305 DRUG

Patients received bevacizumab and FOLFOX4 every two weeks

Also known as: FOLFOX4

Bevacizumab combine with FOLFOX4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Interventions

Folfox protocol

Study Officials

• xuehao wang

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

yongxiang xia, doctor

CONTACT

86-025-68303211; yx_xia@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hepatobiliary Center；Academician of Chinese Academy of Engineering

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 2, 2022
• Study Start: May 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: December 31, 2024
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)