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Sorafenib Combined With Aspirin to Prevent the Recurrence in High-risk Patients With Hepatocellular Carcinoma

11. februar 2019 opdateret af: Lunxiu Qin, Fudan University

A Prospective Randomized Control Trial of the Effect of Sorafenib Combined With Aspirin in Preventing the Recurrence in High-risk Patients With Hepatocellular Carcinoma

The purpose of the study is to observe the effect of sorafenib combined with aspirin in preventing the recurrence in high-risk patients with hepatocellular carcinoma.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

The recurrence of hepatocellular carcinoma(HCC)is the main problem during the treatment. Although some methods such as interferon may be effective in preventing the recurrence, there is still no clear effective approach widely accepted for everyone.

Sorafenib, a kind of tyrosine kinase inhibitor, which inhibiting proliferation and inducing apoptosis of tumor cell by inhibiting the raf/MEK/ERK pathway, and anti-angiogenesis by targeting Vascular Endothelial Growth Factor Receptor(VEGFR), has now become the standard treatment of advanced HCC patients. Although the STORM studies have shown that adjuvant sorafenib for such patients did not significantly affect recurrence-free survival, time to recurrence, or overall survival. The patients recruiting in the study were mostly early stage, for middle and late stage patients, whether sorafenib can reduce tumor recurrence after surgical resection and prolong survival remains to be further study.

Aspirin is a kind of nonsteroidal anti-inflammatory drugs. It is the first hint of aspirin's potential role in tumor prevention and treatment when Gasic found that tumor metastasis is reduced in thrombocytopenia mice, and then the research confirmed that aspirin treatment can significantly reduce the tumor metastasis. In recent years, a lot of epidemiological evidence and clinical trials found that aspirin played an important role in cancer prevention, at the same time, more experimental study has found that it can also play a role in tumor treatment. Our previous animal experiments found that a combination of sorafenib and aspirin can reverse the negative effect of sorafenib which promoted tumor metastasis, and obviously prolong survival of a tumor-burdened nude mice.

So, the study is to observe the effect of sorafenib combined with aspirin in preventing the recurrence in high-risk patients with hepatocellular carcinoma.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

52

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

      • Shanghai, Kina, 200040
        • Huashan 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 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • The characteristics of the treatment history:

    1. No sorafenib treatment history, no sorafenib allergies.
    2. No chemotherapy, radiotherapy and transcatheter arterial chemoembolization(TACE) treatment history before surgery.
  • The characteristics of the tumor:

    1. The pathological results is hepatocellular carcinoma.
    2. Meet any of the following articles:

      • Pathological prompt microvascular invasion(MVI) class II, and incorporate any of the following:Tumor number>3,Tumor size>8cm,Tumor margin is not clear and no complete capsule.
      • With the embolus in Portal vein, hepatic vein or bile duct.
      • Preoperative rupture or invasion the adjacent organs.
      • The positive cut edge.
      • Residual lesions showed by Postoperative digital subtraction angiography(DSA).
      • Alpha fetoprotein(AFP) did not drop to normal range two months after surgery.
  • The characteristics of the patients:

    1. The patient age was between 18-75.
    2. The American Society of Anesthesiologists(ASA)score was I-III.
    3. No history of esophageal varices and gastrointestinal bleeding.
    4. The Child-pugh score was A.
    5. Routine blood test: the leukocyte>2.5*10^9, platelet> 60*10^9.
    6. The Prothrombin time was prolonged less than 2 second.
    7. The Eastern Cooperative Oncology Group(ECOG) score was less than 2 points

Exclusion Criteria:

  • Sorafenib treatment before surgery.
  • Pregnant or lactating women.
  • The Child-pugh score was B-C.
  • Patients with other malignant tumor.
  • Patients with mental illness.
  • Patients participated in other clinical trials in last three months.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: control
just follow up after liver resection in HCC patients
just follow up
Aktiv komparator: sorafenib
use sorafenib after liver resection in HCC patients
sorafenib 400mg bid po
Andre navne:
  • sorafenib treatment
Aktiv komparator: sorafenib and aspirin
use sorafenib and aspirin after liver resection in HCC patients
sorafenib 400mg bid po
Andre navne:
  • sorafenib treatment
aspirin 100mg qd po
Andre navne:
  • aspirin treatment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Samlet overlevelse
Tidsramme: 5 år
5 år

Sekundære resultatmål

Resultatmål
Tidsramme
Sygdomsfri overlevelse
Tidsramme: 5 år
5 år
Number of patients with treatment-related bleedings who use aspirin
Tidsramme: 5 years
5 years

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Lunxiu Qin, MD, Department of general surgery, Huashan hospital, Fudan University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. april 2016

Primær færdiggørelse (Faktiske)

11. februar 2019

Studieafslutning (Faktiske)

11. februar 2019

Datoer for studieregistrering

Først indsendt

12. april 2016

Først indsendt, der opfyldte QC-kriterier

21. april 2016

Først opslået (Skøn)

22. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. februar 2019

Sidst verificeret

1. februar 2019

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 .

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