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

5 maj 2022 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Förväntat)

15

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210029
        • Jiangsu Province Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Bevacizumab Biosimilar IBI305
Patients received bevacizumab and FOLFOX4 every two weeks
Andra namn:
  • FOLFOX4

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Objective Response Rate (ORR) ,Based on RECIST 1.1
Tidsram: 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 )

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-free Survival (PFS), Based on RECIST 1.1 and mRECIST
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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 )

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Utredare

  • Studiestol: xuehao wang, The First Affiliated Hospital with Nanjing Medical University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

1 maj 2022

Primärt slutförande (Förväntat)

31 maj 2023

Avslutad studie (Förväntat)

31 december 2024

Studieregistreringsdatum

Först inskickad

20 april 2022

Först inskickad som uppfyllde QC-kriterierna

26 april 2022

Första postat (Faktisk)

2 maj 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 maj 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 maj 2022

Senast verifierad

1 maj 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2021-SR-380

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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