Clinical trial NCT05355155: Bevacizumab Biosimilar Plus FOLFOX4 in the Treatment of Recurrent HCC After Liver Transplantation
Official title: An Exploratory Study of Bevacizumab Combined With FOLFOX4 in the Treatment of Recurrent Hepatocellular Carcinoma (HCC) After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Post-orthotopic Liver Transplantation
Hepatocellular Carcinoma Recurrent
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Objective Response Rate (ORR) ,Based on RECIST 1.1
timeFrame: 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:
measure: Progression-free Survival (PFS), Based on RECIST 1.1 and mRECIST
timeFrame: 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 )
measure: Disease Control Rate (DCR) ,Based on RECIST 1.1 and mRECIST
timeFrame: 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)
measure: Duration of Response (DOR) ,Based on RECIST 1.1 and mRECIST
timeFrame: 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.
measure: Overall Survival (OS)
timeFrame: From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )
measure: Time-to Response (TTR) Based on RECIST1.1 and mRECIST
timeFrame: From date of first dose of study drug until CR or PR (up to approximately 2 years
measure: Objective Response Rate (ORR) ,Based on mRECIST
timeFrame: 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 )
measure: Safety as measured by number and grade of adverse events
timeFrame: From first dose until 30 days after the last dose (up to approximately 2 years )
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: xuehao wang
role: STUDY_CHAIR
References: