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Adjuvant Therapy With Thalidomide After Curative Resection of Hepatocellular Carcinoma

Adjuvant Therapy With Thalidomide After Curative Resection of Hepatocellular Carcinoma.: a Randomized Controlled Trial

Postoperative recurrence of hepatocellular carcinoma (HCC) is a major problem after surgical resection. To date, adjuvant chemotherapy or other adjuvant modalities have not been proven effective in preventing or delaying recurrence. The aim of this prospective randomized study was to evaluate the effectiveness of Thalidomide as a postoperative adjuvant regimen in inhibiting the recurrence of HCC

Studieoversigt

Status

Ukendt

Intervention / Behandling

Detaljeret beskrivelse

A number of modalities for preventing HCC recurrence after resection have been proposed and analyzed. Both preoperative and adjuvant transcatheter arterial chemoembolization (TACE) were found to be unable to reduce the risk of postoperative recurrence significantly, or confer a survival advantage. Vitamin K (VK) is a fat-soluble vitamin that regulates clotting factor production by acting as a coenzyme for a VK dependent carboxylase that catalyzes carboxylation of glutamic acid residues into gamma-carboxyglutamic acid. The findings in vitro have indicated that VK2 has an antiproliferative effects against hepatoma cell lines, but its efficacy in suppressing HCC recurrence was not confirmed in human studies. Interferon has a variety of biologic properties, including antiviral, immunomodulatory, antiproliferative, antiangiogenic and tumoricidal effects. It is reported that interferon is effective in preventing the development of HCC recurrence after its curative treatment in HCV-related cirrhosis. However, interferon treatment also has side-effects, including flu-like symptoms, fatigue, neutropenia, thrombocytopenia, depression, bone marrow suppression, and unmasking or exacerbation of autoimmune illnesses, which lead either to treatment disruption or dose modification. Polyprenoic acid, an acyclic retinoid, reportedly is effective in prevention of second primary hepatomas, but long-term safety and efficacy data are lacking.

Thalidomide possesses immunomodulatory,anti-inflammatory, and antiangiogenic properties.It has successfully been applied for the treatment of various malignancies including HCC.To investigated whether postoperative adjuvant therapy with Thalidomide could inhibite the recurrence of HCC after radical resection,we planed to conduct this clinical trial.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

140

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Fujian
      • Xiamen, Fujian, Kina, 361003
        • Rekruttering
        • First Affiliated Hospital of Xiamen University
        • Kontakt:
        • Ledende efterforsker:
          • Bin Li
        • Ledende efterforsker:
          • Lu-Peng Wu
        • Ledende efterforsker:
          • Xiu-Dong Li
        • Ledende efterforsker:
          • Xu Su

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 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. 18-75 years old,male and female
  2. Patients who did not receive any anti-tumor therapies prior to the surgery (including liver transplantation, TACE, local tumor ablation, chemotherapy, radiotherapy, molecular targeted therapy and other anti-tumor therapy) resection of hepatocellular carcinoma
  3. Patients who underwent radical resection of HCC, and 1 month after surgery,dynamic computed tomography showed on lesion in the liver and no signs of extrahepatic metastasis
  4. Sign the informed consent

Exclusion Criteria:

  1. Women who were pregnant or breast-feeding
  2. signs showing recurrence or metastasis one month after surgery
  3. Recurrent HCC
  4. Patients unable to take drug orally
  5. Patients inappropriate to participate in the trial upon 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: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Thalidomide
Thalidomide 100mg per day after the radical resection HCC
Patients in the Adjuvant group were given oral Thalidomide(at a dose of 100 mg per day) continuously during the follow-up period
Andre navne:
  • Contergan
Aktiv komparator: Control
No adjuvant Thalidomide treatment after curative hepatic resection
Patients in the Adjuvant group were given oral Thalidomide(at a dose of 100 mg per day) continuously during the follow-up period
Andre navne:
  • Contergan

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
sygdomsfri overlevelse
Tidsramme: 5 år
5 år

Sekundære resultatmål

Resultatmål
Tidsramme
Samlet overlevelse
Tidsramme: 5 år
5 år

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Yanmng Zhou, MD, Xiamen 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. juli 2013

Primær færdiggørelse (Forventet)

1. august 2015

Studieafslutning (Forventet)

1. december 2019

Datoer for studieregistrering

Først indsendt

21. juli 2013

Først indsendt, der opfyldte QC-kriterier

15. august 2013

Først opslået (Skøn)

16. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. august 2013

Sidst verificeret

1. juli 2013

Mere information

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 Thalidomide

3
Abonner