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

NCT07686575 | Recruiting DMC FDA Drug

• 1 other identifier: 2025-KY-452
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

HNSCC; OPSCC; Ivonescimab; OSCC

Keywords

Ivonescimab; oral microbiome; tumor regression grade; paracancerous tissue microbiota; pathological regression extent; tumor tissue microbiota; Salivary microbiota

Outcome Measures

Primary Outcomes (1)

• ORR

  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

Secondary Outcomes (2)

• Tumor regression Pattern

  Perioperative/ Periprocedural

• Two-year progression-free survival rate

  2 Years

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (2)

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

Guangzhou, Guangdong, 510282, China

NOT YET RECRUITING

Department of Stomatology, Zhujiang Hospital, Southern Medical University,Haizhu District

Guangzhou, Guangdong, 510282, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Oral swab;Saliva sample;Tumor tissue ; Paracancerous tissue

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Xiaozhi LV

CONTACT

02062783160; lxzsurgeon@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: July 7, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)