Objective Response Rate of Ivonescimab With Chemotherapy in Locally Advanced Resectable Oral and Oropharyngeal Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）.
- Who it may be relevant to
- Registry conditions: HNSCC, OSCC, OPSCC, Ivonescimab. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Drug 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
Primary outcome measures
- ORR [Time frame: Up to 8 weeks]
Secondary outcome measures (2)
- Tumor regression Pattern [Time frame: Perioperative/ Periprocedural]
- Two-year progression-free survival rate [Time frame: 2 Years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Department of Stomatology, Zhujiang Hospital, Southern Medical University, Haizhu District — Guangzhou
- Department of Stomatology, Zhujiang Hospital, Southern Medical University,Haizhu District — Guangzhou
Identifiers
NCT: NCT07686575 · 2025-KY-452