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

5. května 2022 aktualizováno: Xuehao Wang, The First Affiliated Hospital with Nanjing Medical University

An Exploratory Study of Bevacizumab Combined With FOLFOX4 in the Treatment of Recurrent Hepatocellular Carcinoma (HCC) After Liver Transplantation

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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

Typ studie

Intervenční

Zápis (Očekávaný)

15

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: yongxiang xia, doctor
  • Telefonní číslo: 86-025-68303211
  • E-mail: yx_xia@njmu.edu.cn

Studijní místa

  • Čína
    • Jiangsu
      • Nanjing, Jiangsu, Čína, 210029
        • Jiangsu Province Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 80 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: Bevacizumab Biosimilar IBI305
Patients received bevacizumab and FOLFOX4 every two weeks
Ostatní jména:
  • FOLFOX4

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Objective Response Rate (ORR) ,Based on RECIST 1.1
Časové okno: 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 )
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 )

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression-free Survival (PFS), Based on RECIST 1.1 and mRECIST
Časové okno: 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 )
PFS was defined as the time from the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) based on RECIST 1.1 and mRECIST assessed by investigator review. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions).
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
Časové okno: 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)
the proportion of patients who achieved CR, PR, or SD as their best overall response
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
Časové okno: 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.
From date of first documented confirmed CR or PR until date of first documentation of PD or death whichever occurred first (up to approximately 2 years)
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)
Časové okno: From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )
From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )
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
Časové okno: From date of first dose of study drug until CR or PR (up to approximately 2 years
TTR was defined as the time from the date of first study dose to the date of first documentation of CR or PR, in participants with confirmed CR or PR. It was evaluated according to RECIST1.1 and mRECIST assessed by investigate.
From date of first dose of study drug until CR or PR (up to approximately 2 years
Objective Response Rate (ORR) ,Based on mRECIST
Časové okno: 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 )
ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on mRECIST) assessed by investigator analysis.
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 )
Safety as measured by number and grade of adverse events
Časové okno: From first dose until 30 days after the last dose (up to approximately 2 years )
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
From first dose until 30 days after the last dose (up to approximately 2 years )

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

The First Affiliated Hospital with Nanjing Medical University

Vyšetřovatelé

  • Studijní židle: Xuehao Wang, The First Affiliated Hospital with Nanjing Medical University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Očekávaný)

1. května 2022

Primární dokončení (Očekávaný)

31. května 2023

Dokončení studie (Očekávaný)

31. prosince 2024

Termíny zápisu do studia

První předloženo

20. dubna 2022

První předloženo, které splnilo kritéria kontroly kvality

26. dubna 2022

První zveřejněno (Aktuální)

2. května 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. května 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. května 2022

Naposledy ověřeno

1. května 2022

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

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NE

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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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