ClinicalTrials.gg
Active, not recruitingNCT07686575Updated Oct 27, 2026

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

An observational study in HNSCC, OSCC and OPSCC, sponsored by Zhujiang Hospital. Active, not recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Zhujiang Hospital · Observational

Updated Oct 27, 2026Now Active, not recruitingPrimary completion movedGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 290 studies in Squamous Cell Carcinoma of Head and Neck with a site in China — 171 open to participants now, 205 under way, 25 of them phase 3. Squamous Cell Carcinoma of Head and Neck · China.

Planned enrollment
24th of 25
20 · median 136
Started
2026
with 53 others
Observational
25 of 290
13 open now
Primary completion
2026-10
later than 77 of 204 live
Registered
238th of 290
by date

Among the 290 studies in Squamous Cell Carcinoma of Head and Neck with a site in China, this one is the 24th largest by planned enrollment of the 25 observational ones that give a count, is one of 54 that started in 2026, is one of 25 observational ones, reaches primary completion later than 77 of the 204 other live ones, and was the 238th registered.

Squamous Cell Carcinoma of Head and Neck

2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Open to participants now

171 of the 290 studies in Squamous Cell Carcinoma of Head and Neck with a site in China are open now. Recruiting first, the newest first:

166 more — sign in →

All 171 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 435 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 311 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 290 studies in Squamous Cell Carcinoma of Head and Neck with a site in China, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • HNSCC
  • OSCC
  • OPSCC
  • Ivonescimab

Keywords

  • Ivonescimab
  • oral microbiome
  • tumor regression grade
  • paracancerous tissue microbiota
  • pathological regression extent
  • tumor tissue microbiota
  • Salivary microbiota
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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; (PLT) count ≥75×10⁹/L; (Hb) concentration ≥80g/L
  5. Liver function: (AST) and Alanine transaminase (ALT) ≤2.5 times the (ULN)
  6. Kidney function: Estimated (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 Form (ICF)

Exclusion criteria

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 criteria resulting from prior anticancer therapy
  4. Other conditions deemed unsuitable for study participation by the investigators, including patients with diseases or those at high risk of bleeding due to various causes
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • DrugIvonescimab(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.

06

What researchers measure

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).

    Time frame: Up to 8 weeks

Secondary outcomes

  1. 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.

    Time frame: Perioperative/ Periprocedural

  2. Two-year progression-free survival rate

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

    Time frame: 2 Years

07

Study locations

2 sites
  • Department of Stomatology, Zhujiang Hospital, Southern Medical University, Haizhu District, Guangzhou
    Guangzhou, Guangdong 510282, China
  • Department of Stomatology, Zhujiang Hospital, Southern Medical University,Haizhu District
    Guangzhou, Guangdong 510282, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Oct 2026, 9 months after the start.

Of 108 non-industry observational studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 132. This study's planned 9 months is below that.

Counting every sponsor, half of 118 studies reached it within 81 months; a quarter within 29 and three quarters within 132.

Primary completion moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Oct 27, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 28, 2025
First posted
Jul 7, 2026
StartActual
Jan 26, 2026
Primary completionEst.
Oct 30, 2026was Aug 2026
CompletionEst.
Aug 30, 2028
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 27, 2026
Primary completion
Aug 30, 2026→Oct 30, 2026
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Recruiting→Active, not recruiting
    Primary completion Aug 30, 2026→Oct 30, 2026
    + 2 other changes: contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07686575
Lead sponsor
Zhujiang Hospital
Responsible party
Sponsor
First posted
Jul 7, 2026
Start date
Jan 26, 2026
Primary completion
Oct 30, 2026 (estimated)
Completion
Aug 30, 2028 (estimated)
Last update
Oct 27, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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