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

5 maggio 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Anticipato)

15

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: yongxiang xia, doctor
  • Numero di telefono: 86-025-68303211
  • Email: yx_xia@njmu.edu.cn

Luoghi di studio

  • Cina
    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210029
        • Jiangsu Province Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Bevacizumab Biosimilar IBI305
Patients received bevacizumab and FOLFOX4 every two weeks
Altri nomi:
  • FOLFOX4

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective Response Rate (ORR) ,Based on RECIST 1.1
Lasso di tempo: 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 )

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free Survival (PFS), Based on RECIST 1.1 and mRECIST
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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 )

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigatori

  • Cattedra di studio: xuehao wang, The First Affiliated Hospital with Nanjing Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 maggio 2022

Completamento primario (Anticipato)

31 maggio 2023

Completamento dello studio (Anticipato)

31 dicembre 2024

Date di iscrizione allo studio

Primo inviato

20 aprile 2022

Primo inviato che soddisfa i criteri di controllo qualità

26 aprile 2022

Primo Inserito (Effettivo)

2 maggio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 maggio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2022

Ultimo verificato

1 maggio 2022

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2021-SR-380

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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