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P2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma.

15. maj 2018 opdateret af: Kansai Hepatobiliary Oncology Group

Randomised Phase II Study of Postoperative Hepatic Arterial Infusion Chemotherapy (Interferon/Fluorouracil Versus Low-dose Cisplatin/Fluorouracil) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus.

To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy, interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with hepatocellular carcinoma with portal vein tumor thrombus.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

No standard treatment has been established for highly advanced hepatocellular carcinoma (HCC) invading the major branches of the portal vein except for sorafenib. Some reports suggested that hepatic arterial infusion chemotherapy improved survival of these patients. Other reports indicated surgical intervention improved that survival. However, there is no standard adjuvant therapy after liver resection for the patients with HCC with portal vein tumor thrombus in the main or first branch of the portal vein. Our preliminary results showed that combined interferon-alpha and intra-arterial 5-fluorouracil (5-FU) as a postoperative therapy prolonged disease-free and overall survival after liver resection. Hepatic arterial infusion chemotherapy using low-dose 5-FU and cisplatin is also promising regimen for advanced HCC.

Herein, the investigators planed the study to evaluate efficacy (two year survival as primary outcome, and overall-survival as secondary outcome) and safety ( as secondary outcome) in hepatic arterial infusion chemotherapy with continuous infusion of 5-fluorouracil and systemic administration of interferon-alpha or low-dose 5-FU and cisplatin, and to compare the efficacy as randomized control trial.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

66

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
      • Osaka, Japan, 565-0871
        • Rekruttering
        • Osaka University, Graduate School of Medicine
        • Kontakt:
          • Hiroshi Wada
          • Telefonnummer: +81-6-6879-3251

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. hepatocellular carcinoma with histological or evidence or typical findings by CT or MRI.
  2. surgically resectable tumors with tumor thrombus in first branch or main trunk of portal vein.
  3. 20 years old or more.
  4. Eastern Cooperative Oncology Group Performance status of 0 or 1.
  5. Life expectancy of at least 6 months at the pre-treatment evaluation.
  6. Child-Pugh class A or B.
  7. Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements.

white blood cell count >= 2000/microliter, Neutrophil >= 1000/microliter, Hemoglobin >= 9.0 g/dL, Platelet count >= 75000/microliter, Total Bilirubin <= 1.5mg/dl, aspartate aminotransferase(AST) /alanine aminotransferase(ALT) <= 150 IU/L, Serum creatinine <= 1.2mg/dL, Creatinine clearance >= 60 ml/min

-

Exclusion Criteria:

  1. Histological diagnosed combined hepatocellular and cholangiocellular carcinoma.
  2. Extrahepatic tumor spread which affects patient's prognosis.
  3. Hepatic encephalopathy
  4. Active infections except for hepatitis B virus(HBV) and hepatitis C virus(HCV).
  5. Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
  6. Active double cancer
  7. Pregnancy 8-10) Medication or treatment that may affect to the absorption of drug or pharmacokinetics.

11) others, in the investigator's judgment.

-

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Interferon Alfa、Fluorouracil

Interferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks

Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks
Medicin: Interferon Alfa、Fluorouracil

Hepatic Arterial Infusion of 5-fluorouracil combined with systemic administration of Interferon-alpha

Interferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks

Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks

Andre navne:
  • Interferon Alfa ; IFN、
  • Fluorouracil ; 5-FU
Eksperimentel: Cisplatin、Fluorouracil

Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks

Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks
Medicin: Cisplatin、Fluorouracil

Hepatic Arterial Infusion of 5-fluorouracil and Cisplatin (Low-dose FP)

Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks

Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks

Andre navne:
  • Fluorouracil ; 5-FU
  • Cisplatin ； Cispulan

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Two-year overall survival rate
Tidsramme: Two years

Duration: From randomization to evidenced death.

Rate: Number of patients with evidenced death / number of total patients.

2 year survival rate: survival rate at two-year from the randomization
Two years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression free survival time
Tidsramme: two years
Progression free survival time from randomization to tumor progression based on RECIST or recurrence after curative surgery was calculated by Kaplan Meier methods.
two years
Overall survival time
Tidsramme: two years
Overall survival time from randomization to evidence death was calculated by Kaplan Meier methods.
two years
toxicity
Tidsramme: At the end of hepatic arterial infusion chemotherapy (6 months)
The incidence of adverse events evaluated by CTCAE Ver4.0.
At the end of hepatic arterial infusion chemotherapy (6 months)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kansai Hepatobiliary Oncology Group

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2013

Primær færdiggørelse (Faktiske)

1. februar 2018

Studieafslutning (Forventet)

1. februar 2020

Datoer for studieregistrering

Først indsendt

16. april 2013

Først indsendt, der opfyldte QC-kriterier

16. april 2013

Først opslået (Skøn)

18. april 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2018

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KHBO1207
  • UMIN000010425 (Registry Identifier: UMIN)

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Kliniske forsøg med Hepatocellulært karcinom

Kliniske forsøg med Interferon Alfa、Fluorouracil

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kyrgyzstan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner