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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）
  Patients received two cycles of Ivonescimab combined with chemotherapy at a 3-week interval. The therapeutic regimen consisted of Ivonescimab (10 mg/kg) in combination with paclitaxel (135-175 mg/m²) plus cisplatin (80-120 mg/m²) or carboplatin (0.3-0.4 g/m²). Oral swabs 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. Intraope

Первичные конечные точки

• ORR [Срок оценки: Up to 8 weeks]

Вторичные конечные точки (2)

• Tumor regression Pattern [Срок оценки: Perioperative/ Periprocedural]
• Two-year progression-free survival rate [Срок оценки: 2 Years]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Department of Stomatology, Zhujiang Hospital, Southern Medical University, Haizhu District — Гуанчжоу
• Department of Stomatology, Zhujiang Hospital, Southern Medical University,Haizhu District — Гуанчжоу

Идентификаторы

NCT: NCT07686575 · 2025-KY-452

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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