Clinical trial · Observational
Objective Response Rate of Ivonescimab With Chemotherapy in Locally Advanced Resectable Oral and Oropharyngeal Squamous Cell Carcinoma
NCT07686575CI-TRIAL-00117034recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Ivonescimab | — | UNRESOLVED | — |
| OPSCC | Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
| OSCC | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- ORR
- timeFrame
- Up to 8 weeks
- description
- 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 (2)
- measure
- Tumor regression Pattern
- timeFrame
- Perioperative/ Periprocedural
- description
- 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.
- measure
- Two-year progression-free survival rate
- timeFrame
- 2 Years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.