- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03790059
Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma.
15. oktober 2019 opdateret af: fengkai, Southwest Hospital, China
Radiofrequency Ablation Combined With Local Injection of Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma:A Multicenter Prospective Randomized Controlled Trial.
The primary reason for recurrence of hepatocellular carcinoma after radiofrequency ablation (RFA) is the micro-metastatic lesion that has not been ablated and inactivated in the transitional area.Some clinical trials have confirmed that H101(recombinant human adenovirus type 5 injection) has selective oncolysis in a variety of solid tumors.However, there are no reports that H101 which is injected during surgery can improve the efficacy of RFA in liver cancer at present.Therefore,We used a multicenter prospective randomized controlled study as the main method to prospectively compare the short-term and long-term efficacy of RFA combined with H101 group and traditional RFA group in the treatment of small liver cancer (single lesion , diameter less than or equal to 3cm,to evaluate the value of RFA combined with H101 injection in reducing the postoperative recurrence rate of small hepatocellular carcinoma, and to provide a reliable evidence-based medical basis for the selection of treatment methods for small hepatocellular carcinoma.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The primary reason for recurrence of hepatocellular carcinoma after radiofrequency ablation (RFA) is the micro-metastatic lesion that has not been ablated and inactivated in the transitional area.Oncolytic virus H101 is a genetically engineered adenovirus that lacks Elb 55ku protein.Some clinical trials have confirmed that H101 has selective oncolysis in a variety of solid tumors.Furthermore,research shows that the directly dissolving tumor activity of H101 enhanced obviously and activate the body's anti-tumor immune to induce the distal antitumor effect under the condition of mild high temperature (40 ℃ and 42 ℃).The transition zone of RFA can provide the appropriate mild high temperature.However, there are no reports that H101 which is injected during surgery can improve the efficacy of RFA in liver cancer at present.Therefore,We used a multicenter prospective randomized controlled study as the main method to prospectively compare the short-term and long-term efficacy of RFA combined with H101 group and traditional RFA group in the treatment of small liver cancer (single lesion , diameter less than or equal to 3cm,to evaluate the value of RFA combined with H101 injection in reducing the postoperative recurrence rate of small hepatocellular carcinoma, and to provide a reliable evidence-based medical basis for the selection of treatment methods for small hepatocellular carcinoma.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
160
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Chongqing, Kina, 400038
- Rekruttering
- Institute of hepatobiliary surgery,southwest hospital
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Chongqing
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Chongqing, Chongqing, Kina, 400038
- Rekruttering
- Institute of hepatobiliary surgery,southwest hospital
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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 patients understand the content and significance of the study and we obtain a written informed consent from them.
- The patients' gender are not limited and are between the ages of 18 and 75.
- Liver function of Child-Pugh Class A or B;The retention rate of indocyanine green for 15 minutes is less than or equal to 20%.
- The ECOG score is 0.
- The diagnosis was a single hepatocellular carcinoma with a diameter of no more than 3cm.
- There were no other related diseases affecting RFA treatment.
Exclusion Criteria:
- There are tumor emboli in the large vessels of the liver;distant metastasis of HCC.
- The patient has or has had a history of refractory ascites,hepatic encephalopathy, or esophageal varices hemorrhage.
- The patient was complicated with other malignant tumors.
- The patient has severe cardiac, renal and other organ dysfunction.
- In addition to viral hepatitis, there are other active infectious diseases.
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 |
|---|---|
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Eksperimentel: RFA combined with H101 group
The experimental group was RFA combined H101.H101 has oncolysis in HCC after RFA and reduce tumor recurrence.
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Intraoperative injection of H101 can improve the efficacy of RFA in hepatocellular carcinoma.
Andre navne:
Treat the samll HCC with the RFA.
Andre navne:
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Andet: Conventional RFA group
The standard control group was the conventional RFA.Using RFA for the treatment of small HCC.The efficacy was compared with that of the experimental group combined with H101.
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Treat the samll HCC with the RFA.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Tumor-free survival
Tidsramme: two-years tumor-free survival.
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Postoperative tumor-free survival is an evaluation of tumor recurrence and metastasis.It's also an evaluation of the efficacy of the experimental group
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two-years tumor-free survival.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall survival
Tidsramme: two-years overall survival.
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The percentage of patients who receive certain treatments and are still alive after years of follow-up.
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two-years overall survival.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. oktober 2016
Primær færdiggørelse (Forventet)
1. september 2020
Studieafslutning (Forventet)
1. september 2020
Datoer for studieregistrering
Først indsendt
23. december 2018
Først indsendt, der opfyldte QC-kriterier
28. december 2018
Først opslået (Faktiske)
31. december 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. oktober 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. oktober 2019
Sidst verificeret
1. maj 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Virussygdomme
- Infektioner
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Adenocarcinom
- Neoplasmer, kirtel og epitel
- Neoplasmer i fordøjelsessystemet
- Leversygdomme
- DNA-virusinfektioner
- Neoplasmer i leveren
- Karcinom
- Carcinom, hepatocellulært
- Adenoviridae infektioner
Andre undersøgelses-id-numre
- SWH2016LCYB-11
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