Could less surgery be better for head and neck cancer patients?
NCT ID NCT07369882
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether people with advanced head and neck cancer who respond well to immunotherapy can have a smaller, less invasive surgery instead of the standard extensive surgery. The goal is to see if the smaller surgery works just as well at controlling the cancer while improving quality of life and preserving important functions like swallowing and speech. The trial will enroll 60 participants and follow them for up to 5 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- de-escalated surgery (less extensive tumor removal and neck dissection)
- What this could lead to
- If successful, this could show that some patients with head and neck cancer can have smaller surgeries after immunotherapy, preserving more function and quality of life without harming cancer control.
- What could go wrong
- This is a small, early exploratory study with only 60 participants, so results may not apply broadly. There is a risk that less surgery might not control the cancer as well as standard surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients diagnosed with stage III-IVa head and neck squamous cell carcinoma (HNSCC) according to the AJCC 8th edition TNM staging system, who have achieved a partial response (PR) or complete response (CR) after receiving neoadjuvant immunochemotherapy consisting of a PD-1 inhibitor in combination with nab-paclitaxel and carboplatin/cisplatin. * No prior history of other malignant tumors. * Aged between 18 and 75 years. * Normal baseline (preoperative) clinical and laboratory findings: * 1.Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L without the use of granulocyte colony-stimulating factor (G-CSF) within the previous 14 days * 2.Platelet count ≥ 100 × 10⁹/L without blood transfusion within the previous 14 days * 3.Hemoglobin \> 9 g/dL without blood transfusion or erythropoietin use within the previous 14 days * 4.Total bilirubin ≤ 1.5 × upper limit of normal (ULN) * 5\. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN * 6\. Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 mL/min * 7\. Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN * 8\. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Subjects with TSH outside the normal range may be included if total T3 (or FT3) and FT4 are within normal limits * 9\. Normal myocardial enzyme profile (minor laboratory abnormalities judged by the investigator to be clinically insignificant are acceptable) * Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose of study treatment (Cycle 1, Day 1). If the urine test is indeterminate, a serum test must be performed. Non-childbearing females are defined as those who have been postmenopausal for at least one year or have undergone surgical sterilization or hysterectomy. * All subjects (male or female) with reproductive potential must agree to use highly effective contraception (annual failure rate \<1%) during treatment and for at least 120 days after the last dose of study drug, or 180 days after the last dose of chemotherapy. * Adverse events related to neoadjuvant therapy (e.g., bone marrow suppression, thyroiditis, hypothyroidism, hepatitis, nephritis, myocarditis, myositis, etc.) must have been adequately controlled and resolved to grade 0-2 before surgery. Patients assessed by anesthesiology as fit for general anesthesia may be included. * Patients with pre-existing comorbidities prior to neoadjuvant therapy may also be enrolled if evaluated by anesthesiology and deemed able to tolerate general anesthesia. * Signed written informed consent. Exclusion Criteria: * Diagnosis of another malignant tumor, or the primary lesion at the time of neoadjuvant therapy was not oral cancer. * Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to treatment. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment. * History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. * Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV-1/2 antibody). * Untreated active hepatitis B infection, defined as HBsAg positivity with HBV-DNA levels exceeding the upper limit of normal (ULN) at the study site laboratory. Subjects meeting the following criteria may be enrolled: * a. HBV viral load \< 1000 copies/mL (200 IU/mL) prior to first dosing, provided antiviral therapy is administered throughout the study period to prevent viral reactivation * b. Subjects who are anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV-DNA(-) do not require prophylactic antiviral therapy but must undergo close monitoring for viral reactivation. * Active hepatitis C virus (HCV) infection, defined as positive HCV antibody with detectable HCV-RNA above the lower limit of detection. * Pregnant or lactating women. * Presence of severe or uncontrolled systemic diseases, including but not limited to: * 1\. Cardiac disorders: severe arrhythmias (e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or persistent atrial fibrillation), unstable angina, or congestive heart failure (NYHA class ≥ II) * 2\. Vascular diseases: history of unstable angina, myocardial infarction, transient ischemic attack, or stroke within 6 months prior to enrollment * 3\. Poorly controlled hypertension: systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg * 4\. Pulmonary diseases: noninfectious pneumonitis requiring corticosteroid treatment within 1 year before first dosing, or active interstitial lung disease * 5\. Infectious diseases: active infections requiring systemic therapy, or severe uncontrolled infections * 6\. Active pulmonary tuberculosis * 7\. Gastrointestinal diseases: clinically active diverticulitis, intra-abdominal abscess, or intestinal obstruction * 8\. Hepatic disorders: liver cirrhosis, decompensated liver disease, or acute/chronic active hepatitis * 9\. Uncontrolled diabetes mellitus: fasting blood glucose (FBG) \> 10 mmol/L * 10\. Renal dysfunction: urine protein ≥ ++ on routine urinalysis and 24-hour urinary protein \> 1.0 g * 11\. Psychiatric disorders: severe mental illness that may affect treatment compliance.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 510120, China
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Other studies related to the condition(s) this trial covers.
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- Cutting radiation after surgery: a new hope for head and neck cancer patients?
- Can a new drug boost radiation's power against head and neck cancer in older patients?
- Could skipping some neck radiation spare patients side effects?