Response-adapted Postoperative Radiotherapy In Locally Advanced Head and Neck Cancer

NCT07780877 | Not Yet Recruiting Phase 2

• 1 other identifier: 2606346-4
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief 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. 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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 year

Secondary Outcomes (5)

• Progression-free survival rate

  2 year

• Overall survival rate

  2 year

• Major pathologic response

  6 month

• Adverse events

  2 year

• Swallowing function

  2 year

Study Arms (3)

High-risk Group

ACTIVE COMPARATOR

Standard of care. Adjuvant radiotherapy/chemo-radiotherapy based on pathologic findings

Radiation: Standard adjuvant radiotherapy based on pathologic findings

Intermediate-risk Group

EXPERIMENTAL

De-escalated radiotherapy. Reduced the dose of elective nodal irradiation.

Radiation: De-escalated radiotherapy with a reduced dose

Low-risk Group

EXPERIMENTAL

De-escalated radiotherapy. Omit elective nodal irradiation.

Radiation: De-escalated radiotherapy with omission of ENI

Interventions

Standard adjuvant radiotherapy based on pathologic findings RADIATION

Standard adjuvant radiotherapy based on pathologic findings

High-risk Group

De-escalated radiotherapy with a reduced dose RADIATION

De-escalated radiotherapy: reduce the dose of elective nodal irradiation (ENI).

Intermediate-risk Group

De-escalated radiotherapy with omission of ENI RADIATION

De-escalated radiotherapy: omit elective nodal irradiation (ENI).

Low-risk Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Fudan University: lead
• Hunan Cancer Hospital: collaborator

Study Sites (2)

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yu Wang, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

• Xiaomin Ou, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomin Ou, M.D.

CONTACT

+8618017317872; xiaomin_ou@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Chief Attending Physician, Chair of Department of Head and Neck Surgery

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)