Head & Neck Squamous Cell CarcinomaPhase 2NCT07780877
Response-adapted Postoperative Radiotherapy In Locally Advanced Head and Neck Cancer
A Phase 2 study testing Standard adjuvant radiotherapy based on pathologic findings, De-escalated radiotherapy with a reduced dose and De-escalated radiotherapy with omission of ENI in people with Head & Neck Squamous Cell Carcinoma and Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Fudan University at 2 sites in China.
Trial summary
This was a phase II clinical study. Patients with histologically confirmed, resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) without distant metastasis were enrolled. Enrolled patients received three cycles of neoadjuvant immunotherapy combined with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head & Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Standard adjuvant radiotherapy based on pathologic findings, De-escalated radiotherapy with a reduced dose and De-escalated radiotherapy with omission of ENI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2026to Aug 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
- Patients who have signed the informed consent form and are willing to complete the study according to the protocol;
- Age ≥18 years and ≤75 years;
- Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN), with the primary tumorlocated in the oropharynx, oral cavity, larynx, or hypopharynx;
- Resectable, locally advanced squamous cell carcinoma of the head and neck without distant metastasis (AJCC8th edition: HPV-negative SCCHN: Stage III-IVB; HPV-positive oropharyngeal cancer: T1-4N1-3M0 or T3-4N0M0);
- At least one measurable lesion prior to treatment that meets the criteria for "measurable disease" according toRECIST version 1.1;
- Expected survival >3 months;
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Adequate organ function, meeting the following requirements: a. Absolute neutrophil count (ANC) ≥1.5×10⁹/L; b. Platelet count ≥100×10⁹/L; c. Hemoglobin ≥9 g/dL; d. Serum albumin ≥2.8 g/dL; e. Total bilirubin ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or alkalinephosphatase (ALP) ≤3×ULN; f. Serum creatinine ≤1.5×ULN and creatinine clearance ≥60 mL/min (Cockcroft-Gault formula); g. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5×ULN (patients receiving stable-dose anticoagulant therapy such as low-molecular-weight heparin or warfarin with an INR within the expected therapeutic range of the anticoagulant may be screened);
- Patients with hepatitis B virus (HBV) infection, including inactive/asymptomatic HBV carriers or those withchronic or active HBV, are eligible for enrollment if HBV DNA <500 IU/mL (or 2,500 copies/mL) at screening.Patients with positive hepatitis C antibody are eligible for enrollment if HCV-RNA is negative at screening;
- Women of childbearing potential must have a negative urine or serum pregnancy test within ≤7 days prior totreatment. They must also use a medically acceptable method of contraception (e.g., intrauterine device, oralcontraceptive, or condom) during study treatment and for at least 3 months after the last dose of PD-1 inhibitorand at least 6 months after the last dose of chemotherapy;
- Non-sterilized male subjects must be willing to use a medically acceptable method of contraception (e.g.,intrauterine device, oral contraceptive, or condom) during study treatment and for at least 3 months after the last dose of PD-1 inhibitor and at least 6 months after the last dose of chemotherapy.
Who cannot join
- Prior or concurrent malignancy (except for malignancies cured with disease-free survival >5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma);
- Receipt of any of the following treatments: a. Any investigational drug within 4 weeks prior to the first dose of study drug. b. Concurrent enrollment in another clinical study, except for observational (non-interventional) clinical studies. c. Requirement for systemic corticosteroids at a dose >10 mg/day prednisone equivalent or other immunosuppressive agents within 2 weeks prior to the first dose of study drug, except for corticosteroids used for local inflammation or for prophylaxis of allergy, nausea, and vomiting. Other special circumstances require discussion with the investigator. In the absence of active autoimmune disease, inhaled or topical corticosteroidsand adrenal corticosteroid replacement at doses >10 mg/day prednisone equivalent are permitted. d. Receipt ofantitumor vaccines or live vaccines within 4 weeks prior to the first dose of study drug (for COVID-19 vaccination,an interval of >2 weeks between vaccination and treatment is required). e. Major surgery or severe trauma within 4weeks prior to the first dose of study drug.
- Prior radiotherapy to the head and neck region;
- Uncontrolled cardiac symptoms or diseases, such as: a. New York Heart Association (NYHA) Class II or higher heart failure; b. Unstable angina; c. Myocardial infarction within 1 year; d. Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
- Severe infection (Common Terminology Criteria for Adverse Events [CTCAE] grade >2) within 4 weeks prior tothe first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, or complicated infections; active pulmonary inflammation indicated by baseline chest imaging; or presence of signs and symptoms of infection within 4 weeks prior to the first dose of study drug, or requirement for oral or intravenous antibiotic therapy;
- Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); excluding autoimmune-mediated hypothyroidism managed with a stable dose of thyroid replacement hormone, Type 1 diabetes mellitus managed with a stable dose of insulin, vitiligo, or childhood asthma/allergy that has resolved and requires no intervention in adulthood;
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- History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation;
- History of interstitial lung disease (excluding radiation pneumonitis not treated with corticosteroids) or historyof non-infectious pneumonitis;
- Active tuberculosis infection identified by medical history or CT examination, or history of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection >1 year prior without formal treatment;
- Active hepatitis B (HBV DNA ≥500 IU/mL or 2,500 copies/mL) or hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of detection of the assay);
- Known history of psychoactive substance abuse, alcoholism, or drug addiction;
- Pregnant or breastfeeding women;
- Any other condition that, in the opinion of the investigator, may result in premature discontinuation from the study, such as other severe diseases (including psychiatric disorders) requiring concomitant treatment, severely abnormal laboratory values, or family or social factors that may affect subject safety or data collection.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Hunan Cancer Hospital
Changsha, Hunan
Xiaoxi Luo, M.D.
Yaqian Han, M.D.
Fudan University Shanghai Cancer Center
Shanghai
Xue Gong, +8613611967175, 1360020820@qq.com
Yu Wang, M.D.
About this study
Official title: The Efficacy And Safety Of Response-adapted Postoperative Radiotherapy In Locally Advanced Head and Neck Squamous Cell Carcinoma After Neoadjuvant Chemotherapy and Immunotherapy
This was a phase II clinical study. Patients with histologically confirmed, resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) without distant metastasis were enrolled. Enrolled patients received three cycles of neoadjuvant immunotherapy combined with chemotherapy. Radical surgery was performed 3-5 weeks after completion of the third neoadjuvant cycle, with the requirement of achieving negative surgical margins (R0 resection). Adjuvant radiotherapy was administered based on postoperative pathological findings.
- Conditions
- Head & Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma
- Being tested
- Standard adjuvant radiotherapy based on pathologic findings, De-escalated radiotherapy with a reduced dose, De-escalated radiotherapy with omission of ENI
- Keywords
- head and neck cancer, Locally advanced head and neck cancer, Surgery, Radiation, Radiotherapy, Immunotherapy, PD-1 inhibitor, Pathologic complete response, Major pathologic response, Pathologic response, Response-adapted radiotherapy, De-escalated radiotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard adjuvant radiotherapy based on pathologic findingsRadiation
Standard adjuvant radiotherapy based on pathologic findings
De-escalated radiotherapy with a reduced doseRadiation
De-escalated radiotherapy: reduce the dose of elective nodal irradiation (ENI).
De-escalated radiotherapy with omission of ENIRadiation
De-escalated radiotherapy: omit elective nodal irradiation (ENI).
| Study group | Role | What they receive |
|---|---|---|
| High-risk Group | Active comparator | Standard of care. Adjuvant radiotherapy/chemo-radiotherapy based on pathologic findings Receives: Radiation: Standard adjuvant radiotherapy based on pathologic findings |
| Intermediate-risk Group | Experimental | De-escalated radiotherapy. Reduced the dose of elective nodal irradiation. Receives: Radiation: De-escalated radiotherapy with a reduced dose |
| Low-risk Group | Experimental | De-escalated radiotherapy. Omit elective nodal irradiation. Receives: Radiation: De-escalated radiotherapy with omission of ENI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cervical nodal recurrence
defined as the probability of neck nodal recurrence occurring before local recurrence or distant metastasis, analyzed using a competing risk model.
Measured: 2 year
Secondary outcomes (5)
Progression-free survival rate
Progression-free survival, defined as the time from enrollment to the date of first documented objective tumor progression or death from any cause, whichever occurs first. Patients without documented progression or death at the data cutoff date will be censored.
Measured: 2 year
Overall survival rate
Overall survival, defined as the time from enrollment to death from any cause. Data for patients who are alive at the time of analysis will be censored at the date last known to be alive.
Measured: 2 year
Major pathologic response
Major pathologic response, defined as residual viable tumor cells ≤10% within the surgical tumor bed.
Measured: 6 month
Adverse events
An adverse event is any untoward medical occurrence in a clinical trial subject following administration of a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE may be any unfavourable and unintended sign (including abnormal laboratory findings), symptom, or disease.
Measured: 2 year
Swallowing function
Swallowing function will be assessed using the MD Anderson Dysphagia Inventory (MDADI) and the Eating Assessment Tool-10 (EAT-10).
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Cancer Hospital
- Responsible party
- Principal investigator, Yu Wang, Fudan University
- Investigators
- Yu Wang, M.D., Principal investigator, Fudan UniversityXiaomin Ou, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780877
- Sponsor's protocol ID
- 2606346-4
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy And Safety Of Response-adapted Postoperative Radiotherapy In Locally Advanced Head and Neck Squamous Cell Carcinoma After Neoadjuvant Chemotherapy and Immunotherapy
- ClinicalTrials.gov ID
- NCT07780877
- Acronym / sponsor ID
- 2606346-4
- Conditions
- Head & Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma
- Keywords
- head and neck cancer, Locally advanced head and neck cancer, Surgery, Radiation, Radiotherapy, Immunotherapy, PD-1 inhibitor, Pathologic complete response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Hunan Cancer Hospital
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 24 Aug 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.
This was a phase II clinical study. Patients with histologically confirmed, resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) without distant metastasis were enrolled. Enrolled patients received three cycles of neoadjuvant immunotherapy combined with chemotherapy. Radical surgery was performed 3-5 weeks after completion of the third neoadjuvant cycle, with the requirement of achieving negative surgical margins (R0 resection). Adjuvant radiotherapy was administered based on postoperative pathological findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-risk Group | Active comparator | Radiation: Standard adjuvant radiotherapy based on pathologic findingsStandard of care. Adjuvant radiotherapy/chemo-radiotherapy based on pathologic findings |
| Intermediate-risk Group | Experimental | Radiation: De-escalated radiotherapy with a reduced doseDe-escalated radiotherapy. Reduced the dose of elective nodal irradiation. |
| Low-risk Group | Experimental | Radiation: De-escalated radiotherapy with omission of ENIDe-escalated radiotherapy. Omit elective nodal irradiation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients who have signed the informed consent form and are willing to complete the study according to the protocol;
- Age ≥18 years and ≤75 years;
- Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN), with the primary tumorlocated in the oropharynx, oral cavity, larynx, or hypopharynx;
- Resectable, locally advanced squamous cell carcinoma of the head and neck without distant metastasis (AJCC8th edition: HPV-negative SCCHN: Stage III-IVB; HPV-positive oropharyngeal cancer: T1-4N1-3M0 or T3-4N0M0);
- At least one measurable lesion prior to treatment that meets the criteria for "measurable disease" according toRECIST version 1.1;
Key exclusion criteria (13 listed)
- Prior or concurrent malignancy (except for malignancies cured with disease-free survival >5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma);
- Receipt of any of the following treatments: a. Any investigational drug within 4 weeks prior to the first dose of study drug. b. Concurrent enrollment in another clinical study, except for observational (non-interventional) clinical studies. c. Requirement for systemic corticosteroids at a dose >10 mg/day prednisone equivalent or other immunosuppressive agents within 2 weeks prior to the first dose of study drug, except for corticosteroids used for local inflammation or for prophylaxis of allergy, nausea, and vomiting. Other special circumstances require discussion with the investigator. In the absence of active autoimmune disease, inhaled or topical corticosteroidsand adrenal corticosteroid replacement at doses >10 mg/day prednisone equivalent are permitted. d. Receipt ofantitumor vaccines or live vaccines within 4 weeks prior to the first dose of study drug (for COVID-19 vaccination,an interval of >2 weeks between vaccination and treatment is required). e. Major surgery or severe trauma within 4weeks prior to the first dose of study drug.
- Prior radiotherapy to the head and neck region;
- Uncontrolled cardiac symptoms or diseases, such as: a. New York Heart Association (NYHA) Class II or higher heart failure; b. Unstable angina; c. Myocardial infarction within 1 year; d. Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
- Severe infection (Common Terminology Criteria for Adverse Events [CTCAE] grade >2) within 4 weeks prior tothe first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, or complicated infections; active pulmonary inflammation indicated by baseline chest imaging; or presence of signs and symptoms of infection within 4 weeks prior to the first dose of study drug, or requirement for oral or intravenous antibiotic therapy;
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 |
|---|---|---|
| Standard adjuvant radiotherapy based on pathologic findingsStandard adjuvant radiotherapy based on pathologic findings | Radiation | High-risk Group |
| De-escalated radiotherapy with a reduced doseDe-escalated radiotherapy: reduce the dose of elective nodal irradiation (ENI). | Radiation | Intermediate-risk Group |
| De-escalated radiotherapy with omission of ENIDe-escalated radiotherapy: omit elective nodal irradiation (ENI). | Radiation | Low-risk Group |
Primary outcome
Rate of cervical nodal recurrence
Time frame: 2 year
defined as the probability of neck nodal recurrence occurring before local recurrence or distant metastasis, analyzed using a competing risk model.
5 secondary outcomes
Progression-free survival rate
Time frame: 2 year
Overall survival rate
Time frame: 2 year
Major pathologic response
Time frame: 6 month
Adverse events
Time frame: 2 year
Swallowing function
Time frame: 2 year
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 24 Aug 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.
Yu Wang, M.D. principal investigator
Fudan University
Xiaomin Ou, M.D. principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard adjuvant radiotherapy based on pathologic findings, De-escalated radiotherapy with a reduced dose and De-escalated radiotherapy with omission of ENI in people with Head & Neck Squamous Cell Carcinoma and Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Fudan University 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 11 inclusion and 13 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: opening soon, as of the sponsor's last update on 24 Aug 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.
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?
Contact Xiaomin Ou, M.D. (+8618017317872, xiaomin_ou@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cervical nodal recurrence (time frame: 2 year). 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 24 Aug 2026.