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NCT Number: NCT07686575

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

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.

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Key information

Conditions

HNSCC Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Ivonescimab Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial OPSCC OSCC Squamous Cell Carcinoma of Head and Neck

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Stomatology, Zhujiang Hospital, Southern Medical University, Haizhu District, Guangzhou, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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. Intraoperatively, tumor tissues and paracancerous tissues were harvested, and a 3 mm-thick section of the resected primary tumor lesion was obtained for pathological examination to investigate the tumor regression pattern.

Primary outcomes

  1. ORR

    Time frame: 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).

Secondary outcomes

  1. Tumor regression Pattern

    Time frame: 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.

  2. Two-year progression-free survival rate

    Time frame: 2 Years

    The proportion of patients who remain alive and progression-free for 2 years after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaozhi LV

CONTACT

[email protected]

02062783160

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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