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El ensayo clínico NCT07371234 para Carcinoma de células escamosas de cabeza y cuello localmente avanzado está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Estudio clínico de fase II, unicéntrico y de brazo único, de radioterapia de dosis baja combinada con inmunoterapia con anticuerpos monoclonales anti-PD-1 como tratamiento neoadyuvante para el carcinoma de células escamosas de cabeza y cuello localmente avanzado y resecable quirúrgicamente Fase II 22 Inmunoterapia

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07371234 está diseñado para estudiar el tratamiento de Carcinoma de células escamosas de cabeza y cuello localmente avanzado. Es un estudio intervencionista de Fase II. Su estado actual es: reclutando. El estudio se inició el 15 de diciembre de 2025, con el objetivo de reclutar a 22 participantes. Dirigido por Xiwei XU, se espera que finalice el 30 de diciembre de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 3 de febrero de 2026.
Resumen
Over 60% of head and neck squamous cell carcinoma (HNSCC) patients are diagnosed at a locally advanced stage. While standard treatments involve surgery and chemoradiotherapy, prognosis remains poor, with 50-60% experiencing local recurrence within two years. Neoadjuvant therapy can potentially reduce tumor burden, preserve organs, and lower distant metastasis risk. Despite the KEYNOTE-689 trial showing that adjuvant ...Mostrar más
Título oficial

A Single Arm, Phase II Clinical Study of Low-Dose Radiotherapy Combined With Anti-PD-1 Monoclonal Antibody Immunotherapy as Neoadjuvant Treatment for Surgically Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Condiciones médicas
Carcinoma de células escamosas de cabeza y cuello localmente avanzado
Otros ID del estudio
  • ZDWY.FSZLK.011
Número del NCT
NCT07371234
Inicio del estudio (real)
2025-12-15
Última actualización
2026-02-03
Fecha de finalización (estimada)
2028-12-30
Inscripción (prevista)
22
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Reclutando
Palabras clave
low-dose radiotherapy
neoadjuvant immunotherapy
Locally Advanced Head and Neck Squamous Cell Carcinoma
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalLow-Dose RT plus Anti-PD-1 Imunotherapy Arm
Patients receive low-dose radiotherapy combined with anti-PD-1 monoclonal antibody immunotherapy as neoadjuvant treatment prior to surgical resection.
Neoadjuvant and Adjuvant Immunotherapy
Neoadjuvant therapy with Toripalimab (240mg, Day 1, Q3W, 2 cycles);Adjuvant immunotherapy with Toripalimab (240mg, Day 1, Q3W, for a total of 15 cycles).
Radioterapia de baja dosis
Low-dose radiotherapy (1 Gy/fraction, on Days 1, 8, and 15 of each cycle, Q3W, for 2 cycles; total dose: 6 Gy in 6 fractions).
Cirugía
Radical surgery performed 3-4 weeks after neoadjuvant therapy, following a re-evaluation of surgical indications by the surgeon.
Radioterapia adyuvante
Low-risk group: 60 Gy in 30 fractions, using intensity-modulated radiation therapy (IMRT); High-risk group: 66 Gy in 33 fractions, or 70 Gy in 35 fractions for residual lesions, using intensity-modulated radiation therapy (IMRT).
Adjuvant Cisplatin
High-risk group：Cisplatin 100 mg/m² is administered via intravenous infusion on Day 1 of every 21-day cycle during radiotherapy, for a total of 3 cycles.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Main pathological response rate
The proportion of patients with residual living tumor cells in the tumor bed under microscopy after HE staining of the specimens organized is less than 10%.
1 week post-surgery
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Progression-free survival
From random grouping to the time interval until tumor progression or death for any reason, or until the last follow-up time if there is no tumor progression.
2 years after enrollment treatment
Pathological complete response rate
The proportion of patients with no residual live tumor cells under the microscope.
1 week post-surgery
Objective response rate
Evaluate the proportion of patients with objective response (complete response and partial response) through imaging assessments such as MRI and CT.
3-4 weeks after neoadjuvant therapy
Overall survival
The time interval from random grouping to the time of death for any reason, or to the last follow-up time if there is no death.
2 years after enrollment treatment
Adverse Events Reporting
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
1 year
Head and Neck Cancer-Specific Quality of Life
Changes from baseline in head and neck cancer-specific symptoms and functions were assessed using the EORTC QLQ-H\&N35 module (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Head and Neck Cancer Module). The scores range from 0 to 100, with higher scores indicating a better quality of life outcome and lower scores indicating worse symptoms or functions.
1 year
Health-related Quality of Life
Changes from baseline in patient-reported quality of life were assessed using the EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Version 3.0). The scores range from 0 to 100, with higher scores indicating a better quality of life outcome and lower scores indicating worse symptoms or functions.
1 year
Pathological tumor remission rate -2
The proportion of patients with tumor necrosis under a microscope, where the ratio of keratin fragments and giant cells/tissue cells in tissue sections is not less than 50%.
1 week post-surgery
Non-surgical delay rate
The proportion of patients whose surgical time is more than 4 weeks longer than planned.
8 weeks after two cycles of neoadjuvant therapy
R0 resection rate
The proportion of patients who achieved R0 resection (where the tumor is completely excised during surgery and the margin tissue pathology is negative) among all patients who underwent surgical resection.
1 week post-surgery
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • Voluntarily sign and date the informed consent form.
  • Untreated, histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, or larynx) with CPS ≥1, classified as stage T3-4bN0M0 or T1-4bN1-3M0, corresponding to stage III-IVB according to the AJCC Staging System, 8th Edition.
  • Deemed eligible for curative surgery based on surgeon's assessment.
  • Age: 18 to 75 years.
  • ECOG performance status of 0 or 1.
  • Life expectancy greater than 6 months.
  • At least one measurable lesion as per RECIST 1.1 criteria.
  • Adequate organ function, defined as meeting all the following criteria (without receipt of blood products, colony-stimulating factors, or hematopoietic growth factors within 14 days prior to testing): Hemoglobin ≥ 90 g/L Absolute neutrophil count ≥ 1.5 × 10⁹/L Platelet count ≥ 100 × 10⁹/L Serum albumin ≥ 28 g/L Total bilirubin ≤ 1.5 × upper limit of normal (ULN) ALT and AST ≤ 2.5 × ULN Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min Activated partial thromboplastin time (aPTT) and international normalized ratio (INR) ≤ 1.5 × ULN (patients on a stable dose of anticoagulant therapy such as low molecular weight heparin or warfarin are eligible if INR is within the therapeutic range) Thyroid-stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels must be evaluated, and patients with normal T3 and T4 levels are eligible.
  • Women of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the treatment period and for 3 months after the last dose.
  • Good compliance with the study protocol.

  • Pregnant or lactating women.
  • History of allergy to PD-1 inhibitors.
  • History of other malignancies within the past 5 years or at the time of enrollment, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
  • Uncontrolled cardiac clinical symptoms or diseases, such as: (1) heart failure of NYHA Class II or higher, (2) unstable angina, (3) myocardial infarction within the past year, and (4) patients with clinically significant ventricular or supraventricular arrhythmias requiring intervention.
  • Any of the following prior treatments: ① Receipt of any investigational drug prior to the first dose of the current study drug. ② Concurrent participation in another clinical study, unless it is an observational (non-interventional) study or an interventional study during the follow-up phase. ③ Systemic treatment with corticosteroids (>10 mg prednisone daily or equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of the study drug, with the exception of topical corticosteroid use for local inflammation, prevention of allergic reactions, or management of nausea and vomiting. Inhaled or topical steroids and physiologic replacement doses of corticosteroids (≤10 mg prednisone equivalent daily) are permitted in the absence of active autoimmune disease. ④ Administration of live vaccines within 4 weeks prior to the first dose of the study drug. ⑤ Major surgery or severe trauma within 4 weeks prior to the first dose of the study drug.
  • Severe infection (Grade >2 according to Common Terminology Criteria for Adverse Events), such as severe pneumonia, bacteremia, or complicating infections requiring hospitalization, occurring within 4 weeks prior to the first dose of the study drug; or active pulmonary inflammation or signs/symptoms of infection indicated by baseline chest imaging within 2 weeks prior to the first dose, or requiring oral or intravenous antibiotic treatment (excluding prophylactic antibiotics).
  • History of active autoimmune diseases and syndromes (including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism). Patients with vitiligo not requiring intervention in adulthood, or childhood asthma/allergies that have resolved, are not excluded.
  • History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or history of organ or bone marrow transplantation.
  • Patients with active tuberculosis infection based on medical history or CT findings, or a history of active tuberculosis infection within 1 year prior to enrollment, or a history of active tuberculosis infection more than 1 year ago without adequate course of anti-tuberculosis therapy.
  • Active hepatitis B (HBV DNA ≥ 2,000 IU/mL or 10,000 copies/mL) or hepatitis C (positive HCV antibody test with HCV RNA above the lower limit of detection).
  • Known history of substance abuse, alcohol abuse, or drug use.
  • Considered ineligible for participation based on the investigator's judgment.
Xiwei XU logoXiwei XU
Parte responsable del estudio
Xiwei XU, Investigador-patrocinador, Attending Physician, Fifth Affiliated Hospital, Sun Yat-Sen University
Contactos centrales del estudio
Contacto: Xiaoting Cai, MD, 86-15602268126, [email protected]
1 Centros del estudio en 1 países
The Fifth Affiliated Hospital,Sun Yat-sen University, Guangdong, China
Reclutando