- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00820053
A Trial of Adjuvant Transarterial Chemoembolization (TACE) for Preventing Tumor Recurrence After Liver Resection
Eastern Hepatobilliary Surgical Hospital
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Although resection of hepatocellular carcinoma is potentially curative, local recurrence is common with the recurrence rate higher than 50% during 5 years. So to reduce the recurrence rate of HCC, some interventions had been tried in clinic, including transarterial chemoembolization (TACE), immunotherapy, and interferon treatment etc. But few of these adjuvant therapies had been proved effective and their long term efficacy and clinical application remained further explored.
TACE had been prove to be effective in patients with advanced stage of HCC in randomized controlled trials and meta-analysis, but the role of adjuvant TACE after liver resection is controversial. The results getting from different randomized control trials varied significantly because of the bias of patient selection, different study design,the small size of sample, different drug used in chemotherapy and lack of proper stratification…,so a big sample size, well patients selected and well designed randomized controlled trial is needed to further confirm the role of the postoperative TACE.
Patients with HCC who received curative liver resection (R0) were randomly assigned 1:1 by the doctors to receive no adjuvant TACE(control group) or TACE(treatment group). All patients in the treatment group received adjuvant TACE 45 days after liver resection. The outcomes of patients were evaluated during the 3-years follow up.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Shanghai
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Shanghai, Shanghai, Kina, 200438
- Eastern hepatobilliary surgery hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Male or female patients > 18 years and <=70 years of age.
- Patients with HCC who received curative liver resection (R0).
- 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 .
- Karnofsky Performance Score performance over 60 .
- Patients who can understand this trial and have signed information consent
Exclusion Criteria:
- Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction,which may affect the treatment of liver cancer.
- Patients with other diseases which may affect the treatment mentioned here.
- Patients with 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.
- Patients would not sign the consent to the trial.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: no adjuvant TACE
controll group with patients who don't receive any adjuvant therapy after liver resection, to compare with the treatment group with patients who receive adjuvant TACE after liver resection
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Eksperimentell: adjuvant TACE
patients who adjuvant TACE after liver resection
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using the technology of Seldinger,The drugs (30 mg epirubicin mixed with 5 ml lipiodol) are given via hepatica propria artery.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Total overlevelse
Tidsramme: 2010
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2010
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Tid for gjentakelse
Tidsramme: 2010
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2010
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Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Shen feng, MD, Eastern hepatobilliary surgery hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Adenokarsinom
- Karsinom
- Neoplasmer, kjertel og epitel
- Neoplasmer i fordøyelsessystemet
- Leversykdommer
- Neoplasmer i leveren
- Karsinom, hepatocellulært
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Antibiotika, antineoplastisk
- Epirubicin
- Ethiodisert olje
Andre studie-ID-numre
- EHBH-RCT-2008-014-2
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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