- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04826679
Neoadjuvant Camrelizumab in Combination With Cisplatin and Nab-paclitaxel in Resectable HNSCC
An Open Label, Single Arm Phase II Study of Camrelizumab in Combination With Cisplatin and Nab-paclitaxel as a Novel Neoadjuvant Pre-Surgical Therapy for Resectable HNSCC
This study is a single arm phase II trial including 53 patients with T2N2-3M0、T3-4N0-3M0(III-IV) head and neck squamous cell carcinoma (HNSCC) eligible for resection, who receive neo-adjvuant Camrelizumab combined with cisplatin and Nab-paclitaxel.
This proposed study will evaluate the efficacy and safety of preoperative administration of Camrelizumab combined with chemotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo surgery.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: xuekui Liu
- Telefonnummer: 13609713406
- E-mail: Liuxk@sysucc.org.cn
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina
- Rekruttering
- Sun Yat-sen University
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Kontakt:
- xuekui Liu
- Telefonnummer: 13609713406
- E-mail: Liuxk@sysucc.org.cn
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Confirmed pathologic and/or cytologic diagnosis of squamous cell carcinoma of head and neck,T2N2-3M0、T3-4N0-3M0(III-IV)(AJCC 8.0)
- Greater than or equal to 18 and less than 65 years of age at time of study entry.
- ECOG performance status of 0 or 1.
- Resectable or potentially resectable lesion, without distance metastasis;
- Measurable disease as per RECIST 1.1.
- Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
- Adequate hepatic、cardiac、brain and renal function as demonstrated by 1) Hematology: WBC≥4000/μL、NE≥2.000/μL、HGB≥9 g/dL、PLT≥100000/μL; 2) Renal: Serum creatinine < 1.5x ULN or CrCl > 60mL/min (if using the Cockcroft-Gault formula below): 3) Hepatic: Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3 x ULN);AST/ALT ≤ 3 x ULN and ALP≤3 x ULN;ALB≥3g / dL;
- Ability to understand and willingness to sign an IRB approved written informed consent document. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Exclusion Criteria:
- Severe allergic reaction to any component of PD-1 monoclonal antibodies or other monoclonal antibodies.
- Active, known or suspected autoimmune disease, including dementia and epilepsy.
- Has had another known invasive malignancy or unresectable cancer.
- Coagulation dysfunction: (PT > 16S, APTT > 53s, TT > 21s, FIB < 1.5g / L), bleeding tendency or thrombolysis, anticoagulation treatment.
- Severe cardiac disease, lung dysfunction, heart function and lung function lower than grade 3 (≤3).
- Laboratory abnormality within 7 days before enrollment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
- Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications before enrollment.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has a known history of Hepatitis B (defined as HBV DNA ≥1000 cps/mL is detected) or known active Hepatitis C virus (defined as: HCV antibody positive) infection.
- have received anti-tumor herbs within 4 weeks before randomization.
- Pregnant or nursing women.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Experimental
Camrelizumab + Cisplatin + Nab-paclitaxel Camrelizumab (IV), dose= 200mg , day=1 , cycle length: 21 days. Cisplatin (IV), dose=60mg/m2, day= 1, cycle length: 21 days. Nab-paclitaxel (IV), dose=260mg/m2, day= 1, cycle length: 21 days. |
Patients receive Camrelizumab IV on day 1, nab-paclitaxel IV on day 1 and cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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ORR
Tidsramme: 9 uger
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den samlede svarprocent
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9 uger
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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pCR
Tidsramme: 9 weeks
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Pathological Complete Response
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9 weeks
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MPR
Tidsramme: 9 uger
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Større patologisk reaktion
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9 uger
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DCR
Tidsramme: 9 weeks
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Disease Control Rate
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9 weeks
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PFS
Tidsramme: 2 år
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Progressionsfri overlevelse
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2 år
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OS
Tidsramme: 5 år
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samlet overlevelse
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5 år
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Bivirkninger klassificeret af CTCAE v5.0
Tidsramme: 90 dage efter den første dosis af undersøgelsesbehandlingen
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Procentdel af uønskede hændelser, der muligvis, sandsynligvis eller definitivt er relateret til undersøgelsesbehandling i henhold til Kriterier for bivirkninger version 5 (CTCAE v5.0).
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90 dage efter den første dosis af undersøgelsesbehandlingen
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: xuekui Liu, Sun Yat-sen University
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Neoplasmer i hoved og hals
- Karcinom, pladecelle
- Planocellulært karcinom i hoved og hals
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Paclitaxel
- Cisplatin
Andre undersøgelses-id-numre
- OBU-GD1-BC-HNC-II-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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