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Squamous Cell Carcinoma of the Head and NeckPhase 2NCT07550972

Neoadjuvant Treatment of Locally Advanced HNSCC With Pertuzumab Combined With Lenvatinib.

A Phase 2 study testing A single-arm, single-center clinical trial evaluating efficacy in people with Squamous Cell Carcinoma of the Head and Neck, run by Zhejiang Provincial People's Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

A single-arm, single-center clinical trial evaluating efficacy (Phase #) Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
A single-arm, single-center clinical trial evaluating efficacy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 May 2026to 31 Mar 2030
Phase
Phase 2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1）Understand and voluntarily sign the written informed consent form, and agree to comply with the requirements specified in the protocol.
  • 2) The patient is a first-line patient who has not undergone systemic treatment or radiotherapy for head and neck squamous cell carcinoma.
  • 3) Age ≥18 years and ≤75 years 4) Initial diagnosis confirmed by cytology or histology of squamous cell carcinoma of the head and neck originating from the oral cavity, oropharynx, hypopharynx, or larynx 5) AJCC 8th edition clinical stage III-IVA 6) According to RECIST v1.1, at least one measurable lesion is required. 7) The Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1, with no deterioration within 2 weeks prior to enrollment for the study treatment.
  • 8) Good bone marrow function, defined as meeting all the following criteria and not requiring supportive transfusion or growth factor (CSF, EPO, etc.) therapy within 3 weeks (21 days) prior to administration or within 2 weeks (14 days) prior to administration:
  • Hemoglobin (Hb) ≥9.0 g/dL (90 g/L)
  • Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L
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  • Total platelet count (PLT) ≥100×10⁹/L 9) Good liver function, defined as all of the following conditions:
  • Total bilirubin (TBIL) ≤1.5×ULN (upper limit of normal); for subjects with elevated serum bilirubin due to underlying Gilbert syndrome, familial benign non-conjugate hyperbilirubinemia, or documented hepatic metastases, TBIL ≤2.5×ULN
  • Aspartate aminotransferase (AST) (serum aspartate aminotransferase, SGOT) and alanine aminotransferase (ALT) (serum alanine aminotransferase, SGPT) ≤ 2.5×ULN; in cases of liver metastases, ALT or AST ≤ 3.0×ULN 10) Coagulation function: International Normalized Ratio (INR) or Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN (except for subjects receiving anticoagulant therapy, whose anticoagulant levels should be within the therapeutic range). If the subject is receiving anticoagulant therapy, the investigator should closely monitor these laboratory parameters.
  • 11) Good renal function, defined as creatinine ≤1.5×ULN or serum creatinine clearance (Ccr) ≥50 mL/min (creatinine clearance should be calculated using the corrected Cockcroft-Gault formula. If local guidelines are unavailable, creatinine clearance can be calculated as: Ccr = [(140-age) × body weight (kg) × (0.85 for women only)] / (72 × serum creatinine) (in the absence of significant and uncorrectable electrolyte imbalances).
  • 12) Baseline left ventricular ejection fraction (LVEF) ≥ 50% as measured by multi-gate acquisition (MUGA) or echocardiography (ECHO).
  • 13) Fertile female and male participants must agree to use adequate contraception during the study medication period and for 180 days after the last treatment.
  • Fertile women (those who have not undergone surgical sterilization or have been postmenopausal for less than 1 year) are willing to adopt adequate and reliable contraceptive measures during the study period until 180 days after the last dose of the study drug, such as avoiding heterosexual intercourse, undergoing sterilization procedures, using oral contraceptives, injectable contraceptives, intrauterine devices (IUDs), or condoms.
  • Male subjects must be willing to use latex condoms during any sexual contact with a fertile female, even after successful vasectomy, during the treatment period with the investigational drug and for 180 days after the last treatment. Fertile males are advised to consider obtaining a semen sample prior to the first dose of the drug and storing it for potential future conception.

Who cannot join

  • Pregnant or lactating women
  • Previous history of other malignant tumors within the past 5 years, excluding previously cured basal cell carcinoma of the skin and differentiated thyroid carcinoma.
  • Oral and pharyngeal carcinoma with positive HPV test results
  • Known hypersensitivity to the investigational drugs pertuzumab or lenvatinib
  • Currently using and cannot discontinue potent CYP3A4 inhibitors or inducers
  • Active autoimmune diseases or history of autoimmune diseases
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  • History of immunodeficiency, including HIV-positive status, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and bone marrow transplantation
  • History of mental illness or substance abuse
  • Peripheral neuropathy of grade ≥2 (based on CTCAE 5.0)
  • History of severe cardiac insufficiency, stroke, or transient ischemic attack (TIA) within 6 months prior to enrollment. History of ventricular tachycardia or torsades de pointes. Any clinically significant abnormalities in the rhythm, conduction, or morphology of resting ECG, such as QTcF> 450 ms in males, QTcF> 470 ms in females, complete left bundle branch block, or third-degree atrioventricular block. Presence of clinically significant cardiac disease, including acute myocardial infarction (MI) occurring within 6 months prior to the first study treatment, congestive heart failure (NYHA class III or IV), unstable angina, or arrhythmias requiring treatment. Note: Subjects with arrhythmias may be enrolled if they are receiving antiarrhythmic drug therapy and the screening ECG shows a controlled rhythm.
  • Study of pulmonary embolism or deep vein thrombosis occurring within 3 months prior to the first drug administration.
  • Known history of malignancy (excluding patients who have successfully undergone curative treatment for skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, carcinoma in situ, or papillary thyroid carcinoma), unless the subject has received potentially curative treatment and has had no disease recurrence within 5 years from the start of treatment.
  • Uncontrolled or poorly controlled hypertension (e.g., systolic blood pressure>160 mmHg or diastolic blood pressure>100 mmHg) or hyperglycemia (fasting blood glucose>8.9 mmol/L, or glycated hemoglobin (HbA1c)>8% in type 1 DM subjects).
  • 14）Known active hepatitis B or hepatitis C. Active hepatitis B is defined as known HBsAg positivity with HBV DNA ≥500 IU/mL. Active hepatitis C is defined as known hepatitis C antibody positivity and known quantitative HCV RNA results greater than the detection limit. Other severe liver diseases are present, including chronic autoimmune liver disease, primary biliary cholangitis or cirrhosis, alcoholic liver disease, or non-alcoholic steatohepatitis (NASH).
  • 15）Subjects with a positive pregnancy test or those who are breastfeeding. Female and male subjects who are not expected to use adequate contraception during the treatment period and within 180 days after the last treatment administration.
  • The circumstances that the researchers assessed as unsuitable for inclusion in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

Other trials in China

About this study

Official title: Safety and Efficacy of Pertuzumab Combined With Lenvatinib for Neoadjuvant Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and Neck: A Single-Arm, Single-Center Clinical Study.

A single-arm, single-center clinical trial evaluating efficacy (Phase #)

Read the detailed description

The investigators designed a single-center, single-arm clinical trial. In this trial, patients with resectable locally advanced head and neck squamous cell carcinoma (Stage III-IV) were enrolled as subjects. After obtaining informed consent, eligible patients who met the inclusion and exclusion criteria were selected to receive neoadjuvant standard therapy with pertuzumab combined with lenvatinib. After 2-4 cycles of treatment, surgical intervention was performed, followed by adjuvant therapy (which may include systemic drug therapy and radiotherapy) as determined by the investigators.

Being tested
A single-arm, single-center clinical trial evaluating efficacy
Keywords
squamous cell carcinoma of the head and neck
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.

  • A single-arm, single-center clinical trial evaluating efficacyDrug

    Combination therapy regimen: Pertuzumab combined with lenvatinib for neoadjuvant treatment Each 21-day period constitutes one treatment cycle, with pertuzumab administered at a dose of 3 mg/kg.(Up to 200 mg) Q3W, lenvatinib 8 mg QD.Total of 2-4 cycles.The subjects will undergo surgery subsequently.

    Subsequently, adjuvant therapy was administered.

Study groups in NCT07550972
Study groupRoleWhat they receive
A single-arm, single-center clinical trial evaluating efficacy (Phase #)Active comparatorCombination therapy regimen: Pertuzumab combined with lenvatinib for neoadjuvant treatment Each 21-day period constitutes one treatment cycle, with pertuzumab administered at a dose of 3 mg/kg.(Up to 200 mg) Q3W, lenvatinib 8 mg QD.Total of 2-4 cycles.The subjects will undergo surgery subsequently. Subsequently, adjuvant therapy was administered.
Receives: Drug: A single-arm, single-center clinical trial evaluating efficacy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Progression Rate (MPR)

    Pathological complete response rate of primary tumor after neoadjuvant therapy

    Measured: up to 6 months

Secondary outcomes (6)

  1. pCR

    Pathological complete response rate of primary tumor after neoadjuvant therapy

    Measured: up to 6 months

  2. objective response rate (ORR) in neoadjuvant therapy

    The decline phase following neoadjuvant therapy The treating physician will evaluate the tumor stage according to the American Joint Committee on Cancer (AJCC) TNM staging system (8th edition) after neoadjuvant therapy.

    Measured: up to 6 months

  3. umor regression rate

    The decline phase following neoadjuvant therapy The treating physician will evaluate the tumor stage according to the American Joint Committee on Cancer (AJCC) TNM staging system (8th edition) after neoadjuvant therapy.

    Measured: up to 6 months

  4. organ preservation rate

    The decline phase following neoadjuvant therapy The treating physician will evaluate the tumor stage according to the American Joint Committee on Cancer (AJCC) TNM staging system (8th edition) after neoadjuvant therapy.

    Measured: up to 6 months

  5. 2-year EFS rate

    EFS is defined as the time from the initial treatment date to the first recorded event date, including disease progression.

    Progression, local or distant metastasis as assessed by imaging or biopsy, or death from any cause, whichever occurs first.

    Measured: up to 2 years

  6. 2-year OS rate

    OS was defined as the time from the start of treatment to death from any cause.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion31 Mar 2030 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07550972
Sponsor's protocol ID
KY2025224
Status last verified
Apr 2026
First submitted
19 Apr 2026
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing A single-arm, single-center clinical trial evaluating efficacy in people with Squamous Cell Carcinoma of the Head and Neck, run by Zhejiang Provincial People's Hospital at 1 site 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 14 inclusion and 16 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: enrolling by invitation, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Major Progression Rate (MPR) (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07550972.

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 24 Apr 2026.

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