HNSCCNCT07686575
Objective Response Rate of Ivonescimab With Chemotherapy in Locally Advanced Resectable Oral and Oropharyngeal Squamous Cell Carcinoma
An observational study of HNSCC and OSCC, run by Zhujiang Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 26 Jan 2026to 30 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Stomatology, Zhujiang Hospital, Southern Medical University, Haizhu District, Guangzhou
Guangzhou, Guangdong, 510282
Department of Stomatology, Zhujiang Hospital, Southern Medical University,Haizhu District
Guangzhou, Guangdong, 510282
About this study
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.
Read the 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.
- Conditions
- HNSCC, OSCC, OPSCC, Ivonescimab
- Being tested
- Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）
- Keywords
- Ivonescimab, oral microbiome, tumor regression grade, paracancerous tissue microbiota, pathological regression extent, tumor tissue microbiota, Salivary microbiota
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
According to RECIST version 1.1, it is defined as the proportion of patients who achieved Complete Response (CR) or Partial Response (PR).
Measured: Up to 8 weeks
Secondary outcomes (2)
Tumor regression Pattern
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.
Measured: Perioperative/ Periprocedural
Two-year progression-free survival rate
The proportion of patients who remain alive and progression-free for 2 years after treatment
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start26 Jan 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686575
- Sponsor's protocol ID
- 2025-KY-452
- Status last verified
- Jun 2026
- First submitted
- 28 Dec 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Response Rate of Ivonescimab With Chemotherapy in Locally Advanced Resectable Oral and Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07686575
- Acronym / sponsor ID
- 2025-KY-452
- Conditions
- HNSCC, OSCC, OPSCC, Ivonescimab
- Keywords
- Ivonescimab, oral microbiome, tumor regression grade, paracancerous tissue microbiota, pathological regression extent, tumor tissue microbiota, Salivary microbiota
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. 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. | Drug | – |
Primary outcome
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).
2 secondary outcomes
Tumor regression Pattern
Time frame: Perioperative/ Periprocedural
Two-year progression-free survival rate
Time frame: 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HNSCC and OSCC, run by Zhujiang Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.