Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Cytoreductive Surgery and Transarterial Chemoembolization (TACE) Versus TACE for Hepatocellular Carcinoma (TACE)

10. august 2013 opdateret af: ShenFeng, Eastern Hepatobiliary Surgery Hospital

A Prospective Randomized Trial Comparing Cytoreductive Surgery Followed by Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone for Multinodular Hepatocellular Carcinoma (MNHCC)

The aim of this study is to compare the surgical outcomes of cytoreductive surgery followed by Transarterial Chemoembolization (TACE) with TACE alone in patients with MNHCC so as to establish a treatment standard for MNHCC.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Hepatocellular carcinoma (HCC) is one of the world's most common malignancies, especially in East-Asian countries. Hepatic resection has been accepted as the only means of cure for patients with HCC. The results of hepatic resection for early-stage HCC are favorable.Nevertheless, the role of surgical resection for multinodular HCC (MNHCC) is less well-defined.The presence of multiple tumors has been shown to be one of the most significant independent factors to influence cumulative survival rates in HCC after hepatic resection.Using the BCLC criteria,liver transplantation provides an alternative curative treatment option for MNHCC with size ≤ 5 cm in diameter and tumor number <3，but MNHCC beyond these criteria usually receive palliative therapy.

For MNHCC which not suitable for curative treatment, non-surgical and surgical interventions are available for palliative care.Cytoreductive surgery has the potential to increase the quality and quantity of survival in patients with advanced HCC. Cytoreductive surgery is carried out with partial hepatectomy,cryosurgery,microwave coagulation therapy(MCT),or absolute alcohol injection.It has been shown to prolong survival and provide good symptomatic relief in patients with good surgical risks in non-randomized studies.Cytoreductive surgery aims at removal or destruction of all macroscopic tumours, allowing microscopic foci to persist while preserving as much of the functional liver tissue as possible. The development of effective local ablative therapy (LAT), such as radiofrequency ablation (RFA) therapy, facilitates reduction of the tumour burden even further during the operation.Cytoreductive surgery can also be followed by other non-surgical treatments,such as regional therapy or systemic therapy, to deal with the residual disease or micrometastases.

The aim of this study is to compare the surgical outcomes of cytoreductive surgery followed by TACE with TACE alone in patients with MNHCC so as to establish a treatment standard for MNHCC.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Shanghai
      • Shanghai, Shanghai, Kina, 200438
        • Eastern Hepatobiliary Surgery Hospital

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

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female patients > 18 years and <=70 years of age.
  • at least 2 radiologic imaging showing characteristic features of HCC or one radiologic imaging associated with AFP >400 or cytologic/histologic evidence.
  • tumor number >3 and <=5,maximum diameter >5cm and <=15cm;without evidence of radiologically definable vascular invasion or extrahepatic metastasis.
  • Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
  • No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
  • Hb ≥90g/L,WBC ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³
  • Patients who can understand this trial and have signed information consent

Exclusion Criteria:

  • Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
  • Patients with other diseases which may affect the treatment mentioned.
  • Patients with a medical history of other malignant tumors.
  • Subjects participating in other clinical trials.
  • Extrahepatic metastasis, portal vein or other major vascular involvement.
  • liver function:Child C.
  • no pathological evidence of HCC.

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: TACE
TACE alene
Procedure: TACE
TACE alone or TACE followed by downstage resection for MNHCC
Andre navne:
  • TACE group
Aktiv komparator: Cytoreductive Surgery
Cytoreductive Surgery followed by TACE
Procedure: Cytoreductive Surgery
Cytoreductive Surgery followed by TACE for MNHCC
Andre navne:
  • Cytoreductive group

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
den samlede overlevelsesrate for hver gruppe
Tidsramme: 3 år
3 år

Sekundære resultatmål

Resultatmål
Tidsramme
the disease-free survival rate of each group
Tidsramme: 3 years
3 years

Samarbejdspartnere og efterforskere

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

Sponsor

Eastern Hepatobiliary Surgery Hospital

Efterforskere

  • Studiestol: Weiping Zhou, M.D., Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

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. november 2008

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

8. januar 2009

Først indsendt, der opfyldte QC-kriterier

9. januar 2009

Først opslået (Skøn)

12. januar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. august 2013

Sidst verificeret

1. august 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EHBH-RCT-2008-021

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hepatocellulært karcinom

Kliniske forsøg med Cytoreductive Surgery

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Zimbabwe

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner