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Microwave Ablation in Combination With Camrelizumab Versus Camrelizumab in Metastatic Non-small-cell Lung Cancer (MWA in NSCLC)

29. oktober 2020 opdateret af: Xin Ye, Shandong Provincial Hospital

Shandong Provincial Hospital Affiliated to Shandong University

Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients in the camrelizumab group were treated with camrelizumab with the dose of 200mg on day 1, repeated every 21 days.Patients in the combination group were treated with MWA in the primary tumor followed by camrelizumab with the dose of 200mg on day 1, repeated every 21 days.

The primary end point is overall survival. The second end points include progression free survival, objective response rate and safety.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

200

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Shandong
      • Binzhou, Shandong, Kina, +86 256600
        • Rekruttering
        • Binzhou Medical University Hospital
        • Kontakt:
      • Dezhou, Shandong, Kina, +86 253000
        • Rekruttering
        • Dezhou People's Hospital
        • Kontakt:
      • Dezhou, Shandong, Kina, +86 253000
        • Rekruttering
        • The Second People's Hospital of Dezhou
        • Kontakt:
      • Jinan, Shandong, Kina, +83 250001
        • Rekruttering
        • Jinan Military General Hospital
        • Kontakt:
      • Jinan, Shandong, Kina, +86 250001
        • Rekruttering
        • Affliated Hospital of Shandong Academy of Medical Sciences
        • Kontakt:
      • Jinan, Shandong, Kina, +86053168773172
        • Rekruttering
        • Shandong Provincial Hospital affliated to Shandong University
        • Kontakt:
        • Kontakt:
      • Jining, Shandong, Kina, +86 272000
        • Rekruttering
        • Affliated Hospital of Jining Medical University
        • Kontakt:
      • Liaocheng, Shandong, Kina, +86 252000
        • Rekruttering
        • Liaocheng Cancer Hospital
        • Kontakt:
      • Taian, Shandong, Kina, +86 271000
        • Rekruttering
        • Affliated Hospital of Taishan Medical University
        • Kontakt:
      • Taian, Shandong, Kina, +86 271000
        • Rekruttering
        • The People's Liberation Army 88 Hospital
        • Kontakt:
      • Weifang, Shandong, Kina, +86 262000
        • Rekruttering
        • Weifang People's Hospital
        • Kontakt:
          • Guo hua Yu, M.D
          • Telefonnummer: +86 13685368817
          • E-mail: ghyry@126.com
      • Yantai, Shandong, Kina, +86 264000
        • Rekruttering
        • Yantai Yuhuangding Hospital
        • Kontakt:
      • Zaozhuang, Shandong, Kina, +86 277000
        • Rekruttering
        • Tengzhou center of people's hospital
        • Kontakt:

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

16 år til 78 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Aged 18 to 75 years old
  2. Cytologically or pathologically verified non-small cell lung cancer (NSCLC)
  3. Patients with distant metastases or postoperative recurrence
  4. EGFR or ALK sensitive mutations are negative (all patients, including non-adenocarcinoma patients)
  5. At least one line of platinum-based doublet chemotherapy was administrated
  6. Eastern Cancer Cooperative Group（ECOG）Performance Status（PS）of 0 to 1
  7. At least two measurable tumors (in other words a measurable tumor lesion exclusive primary tumors)
  8. Asymptomatic brain metastases or symptomatic brain metastases under control
  9. If treated with irradiation，at least one month interval between radiation and randomization 10）Cardiopulmonary function, laboratory test indicators without ablation or chemotherapy contraindications

11) Informed conssent can be obtained 12) Sufficient tissue specimens for PD-L1 or TMB or blood samples were provided (1 week before treatment, 1 week after ablation, and once every two months for immune evaluation) for subsequent analysis

Exclusion Criteria:

  1. Mixed lung cancer contains neuroendocrine tumor, small cell lung cancer or sarcoma
  2. Suffering from other malignant tumors within five years
  3. EGFR, ALK sensitive mutations are positive or unknown
  4. ECOG PS≥2
  5. Uncontrolled pleural effusion or pericardial effusion
  6. Uncontrolled symptomatic brain metastases
  7. Previously anti-PD-1, anti-PD-L1, anti-CTLA-4 or Car-T immunotherapy
  8. severe interstitial pneumonia with severe diffuse dysfunction
  9. Autoimmune diseases require long-term hormone therapy patients
  10. Patients required consistent application of prednisone
  11. Uncontrolled pulmonary infection or antibiotics stopped within 1 month
  12. Acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month
  13. Patients during pregnancy or lactation
  14. Life expectance of 3 months or less

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Microwave ablation plus camrelizumab group
Patients in the group are treated with Microwave ablation in the primary tumor, followed by camrelizumab.
Andet: Camrelizumab plus microwave ablation
In the group, microwave ablation will be administrated to the primary tumors, followed by camrelizumab.
Andre navne:
  • Camrelizumab plus MWA
Placebo komparator: Camrelizumab group
Patients in the group are treated with camrelizumab alone.
Medicin: Camrelizumab
Patients will be treated with camrelizumab alone.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective response rate
Tidsramme: The proportion of Patients achieved complete response or partial response up to 16 weeks
ORR
The proportion of Patients achieved complete response or partial response up to 16 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival
Tidsramme: From date of randomization until the date of first documented date of death from any cause，assessed up to 24 months
OS
From date of randomization until the date of first documented date of death from any cause，assessed up to 24 months
Progression free survival
Tidsramme: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
OS
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Safety
Tidsramme: The proportion and grade of patients had adverse events up to 24 months
The adverse events of both microwave and camrelizumab
The proportion and grade of patients had adverse events up to 24 months

Samarbejdspartnere og efterforskere

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

Sponsor

Shandong Provincial Hospital

Efterforskere

  • Ledende efterforsker: Xin Ye, Shandong Provincial Hospital

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 (Faktiske)

1. november 2019

Primær færdiggørelse (Forventet)

31. oktober 2021

Studieafslutning (Forventet)

28. februar 2022

Datoer for studieregistrering

Først indsendt

22. september 2019

Først indsendt, der opfyldte QC-kriterier

23. september 2019

Først opslået (Faktiske)

25. september 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • Shandong PH

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

IPD-planbeskrivelse

Principle of confidentiality

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med NSCLC trin IV

Kliniske forsøg med Camrelizumab plus microwave ablation

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Germany

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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