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Objective Response Rate of Ivonescimab With Chemotherapy in Locally Advanced Resectable Oral and Oropharyngeal Squamous Cell Carcinoma

6. juli 2026 oppdatert av: Zhujiang Hospital

To investigate the neoadjuvant chemoimmunotherapy regimen of Ivonescimab combined with chemotherapy (Paclitaxel plus Cisplatin/Carboplatin) for the treatment of locally advanced resectable oral squamous cell carcinoma and oropharyngeal squamous cell carcinoma.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Legemiddel: Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）

Detaljert beskrivelse

Two cycles of treatment with Ivonescimab combined with chemotherapy were administered, with an interval of 3 weeks between the two cycles. Oral swab and saliva samples were collected within 3 days prior to the initiation of the first cycle of Ivonescimab plus chemotherapy, within 3 days prior to the initiation of the second cycle, and within 3 days prior to surgery. Intraoperatively, tumor tissues and paracancerous tissues were harvested. A 3 mm-thick section of the resected primary tumor lesion was obtained for pathological examination to investigate the tumor regression pattern.

Studietype

Observasjonsmessig

Registrering (Antatt)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Xiaozhi LV
Telefonnummer: 02062783160
E-post: lxzsurgeon@126.com

Studiesteder

Kina
- Guangdong
  - Guangzhou, Guangdong, Kina, 510282
    - Har ikke rekruttert ennå
    - Department of Stomatology, Zhujiang Hospital, Southern Medical University, Haizhu District, Guangzhou
    - Ta kontakt med:
      
      Xiaozhi LV
      
      Telefonnummer: 02062782092
      
      E-post: lxzsurgeon@126.com
    - Ta kontakt med:
      
      E-post: lxzsurgeon@126.com
  - Guangzhou, Guangdong, Kina, 510282
    - Rekruttering
    - Department of Stomatology, Zhujiang Hospital, Southern Medical University,Haizhu District
    - Ta kontakt med:
      
      Xiaozhi LV, MD, PhD
      
      Telefonnummer: 02062782092 02062783160
      
      E-post: lxzsurgeon@126.com
    - Ta kontakt med:
      
      Telefonnummer: 02062782092
      
      E-post: lxzsurgeon@126.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients were diagnosed with oral squamous cell carcinoma (OSCC) (a carcinoma arising from the oral mucosal epithelium with squamous differentiation, involving the mobile tongue, buccal mucosa, gingiva, hard palate, floor of the mouth and other oral mucosal sites) or oropharyngeal squamous cell carcinoma (OPSCC) (a carcinoma arising from the oropharyngeal mucosal epithelium with squamous differentiation, involving the base of tongue, vallecula epiglottica, lateral and posterior walls of the oropharynx, as well as the soft palate and uvula). All patients were confirmed as locally advanced diseases according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging criteria: Stage III/IVA for OSCC or HPV-negative OPSCC, and Stage II/III for HPV-positive OPSCC.

Beskrivelse

Inclusion Criteria:

Histopathologically diagnosed as oral squamous cell carcinoma (OSCC) or oropharyngeal squamous cell carcinoma (OPSCC)
Patients staged according to the AJCC criteria (8th edition) as locally advanced (Stage III/IVA oral cancer, HPV-negative oropharyngeal cancer, or Stage II/III HPV-positive oropharyngeal cancer) and assessed by the investigators as resectable.
Age 18 to 80 years
Complete blood count (CBC): White blood cell (WBC) count ≥3×10⁹/L; Platelet (PLT) count ≥75×10⁹/L; Hemoglobin (Hb) concentration ≥80g/L
Liver function: Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN)
Kidney function: Estimated glomerular filtration rate (eGFR) > 50 mL/min
Patients must have adequate function of vital organs (including cardiac, pulmonary, thyroid, and other organs) and a general condition that allows tolerance of the treatment regimen of this study.
Sign the Informed Consent Form (ICF)

Exclusion Criteria:

Pregnancy or lactation (for female participants)
A history of epilepsy or mental illness that is not effectively controlled
Unresolved toxicities of grade > 2 per CTCAE criteria resulting from prior anticancer therapy
Other conditions deemed unsuitable for study participation by the investigators, including patients with autoimmune diseases or those at high risk of bleeding due to various causes

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
ORR Tidsramme: Up to 8 weeks	According to RECIST version 1.1, it is defined as the proportion of patients who achieved Complete Response (CR) or Partial Response (PR).	Up to 8 weeks

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Tumor regression Pattern Tidsramme: Perioperative/ Periprocedural	Classification of tumor regression as concentric or non-concentric based on pathological assessment of resected primary tumor specimens. Concentric regression pattern: The residual tumor presents as a single mass with scattered microscopic satellite foci in the surrounding tissues. Non-concentric regression pattern: The tumor dissociates into multiple discretenlesions and is widely scatterd within the stroma.	Perioperative/ Periprocedural
Two-year progression-free survival rate Tidsramme: 2 Years	The proportion of patients who remain alive and progression-free for 2 years after treatment	2 Years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Zhujiang Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. januar 2026

Primær fullføring (Antatt)

30. august 2026

Studiet fullført (Antatt)

30. august 2028

Datoer for studieregistrering

Først innsendt

28. desember 2025

Først innsendt som oppfylte QC-kriteriene

6. juli 2026

Først lagt ut (Faktiske)

7. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)