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

2026年7月6日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

20

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Guangdong
      • Guangzhou、Guangdong、中国、510282
        • 尚未招聘
        • Department of Stomatology, Zhujiang Hospital, Southern Medical University, Haizhu District, Guangzhou
        • 接触：
        • 接触：
      • Guangzhou、Guangdong、中国、510282
        • 招聘中
        • Department of Stomatology, Zhujiang Hospital, Southern Medical University,Haizhu District
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

Inclusion Criteria:

  1. Histopathologically diagnosed as oral squamous cell carcinoma (OSCC) or oropharyngeal squamous cell carcinoma (OPSCC)
  2. 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.
  3. Age 18 to 80 years
  4. Complete blood count (CBC): White blood cell (WBC) count ≥3×10⁹/L; Platelet (PLT) count ≥75×10⁹/L; Hemoglobin (Hb) concentration ≥80g/L
  5. Liver function: Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN)
  6. Kidney function: Estimated glomerular filtration rate (eGFR) > 50 mL/min
  7. 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.
  8. Sign the Informed Consent Form (ICF)

Exclusion Criteria:

  1. Pregnancy or lactation (for female participants)
  2. A history of epilepsy or mental illness that is not effectively controlled
  3. Unresolved toxicities of grade > 2 per CTCAE criteria resulting from prior anticancer therapy
  4. 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
ORR
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Tumor regression Pattern
大体时间：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
大体时间：2 Years
The proportion of patients who remain alive and progression-free for 2 years after treatment
2 Years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Zhujiang Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月26日

初级完成 (估计的)

2026年8月30日

研究完成 (估计的)

2028年8月30日

研究注册日期

首次提交

2025年12月28日

首先提交符合 QC 标准的

2026年7月6日

首次发布 (实际的)

2026年7月7日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年7月6日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2025-KY-452

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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