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El ensayo clínico NCT07492914 para Resected Head and Neck Cancer está aún no recluta. 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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Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma Fase II 30 Sin placebo Basado en biomarcadores Etiqueta abierta
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El ensayo clínico NCT07492914 está diseñado para estudiar el tratamiento de Resected Head and Neck Cancer. Este es un estudio intervencionista de Fase II. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 20 de marzo de 2026 hasta completar 30 participantes. Dirigido por West China Hospital, se espera que finalice el 31 de marzo de 2031. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de marzo de 2026.
Resumen
The goal of this clinical trial is to evaluate the anti-tumor activity, safety and tolerability of the combination of Sacituzumab govitecan and Tagitanlimab as neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma (HNSCC). It will also explore potential biomarkers related to the efficacy of this combined therapy. The main questions it aims to answer are:
Does the combination of Sacitu...
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A Single-Arm, Phase II Prospective Study Of Lucanoximab Combined With Tagolimab As Neoadjuvant Therapy For Resectable Head And Neck Squamous Cell Carcinoma
Condiciones médicas
Resected Head and Neck CancerOtros ID del estudio
- 2025(2634)
Número del NCT
Inicio del estudio (real)
2026-03-20
Última actualización
2026-03-25
Fecha de finalización (estimada)
2031-03-31
Inscripción (prevista)
30
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Aún no recluta
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalSacituzumab govitecan + Tagitanlimab Neoadjuvant Therapy Eligible patients with resectable head and neck squamous cell carcinoma (HNSCC) will receive neoadjuvant combination therapy of Sacituzumab govitecan and Tagitanlimab for 2 sequential 2-week treatment cycles. Sacituzumab govitecan is administered intravenously at a dose of 5mg/kg every 2 weeks, and Tagitanlimab is administered intravenously at a fixed dose of 900mg every 2 weeks, with both agents delivered in the sam...Mostrar más | Sacituzumab Govitecan Humanized anti-TROP2 antibody-drug conjugate (ADC) linked to a topoisomerase I inhibitor via a stable linker, featuring high tumor targeting and efficient cytotoxic drug release. Administered intravenously at 5mg/kg every 2 weeks for 2 cycles (90±15 minutes infusion per dose) as neoadjuvant therapy for resectable head and neck squamous cell carcinoma (HNSCC), delivering targeted cytotoxic effects to TROP2-overexpress...Mostrar más Tagitanlimab Humanized IgG1κ anti-PD-L1 monoclonal antibody that blocks the PD-1/PD-L1 signaling pathway to restore T cell-mediated anti-tumor immunity and reverse tumor immune escape. Administered intravenously at a fixed 900mg dose every 2 weeks for 2 cycles (120 minutes infusion per dose) as neoadjuvant therapy for resectable head and neck squamous cell carcinoma (HNSCC), used in combination with Sacituzumab Govitecan to achie...Mostrar más |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Major Pathological Response Rate (MPR) | Major Pathological Response Rate (MPR) is defined as the proportion of enrolled patients with residual viable tumor (RVT) ≤10% in the primary tumor and regional lymph node resection specimens after completion of 2 cycles of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab therapy, assessed per immune-related pathological response criteria (irPRC) by independent pathological reviewers. MPR is the primary efficacy endpoint to evaluate the anti-tumor activity of the combined neoadjuvant regimen in resectable head and neck squamous cell carcinoma (HNSCC). | Assessed at the time of surgical resection (3 to 6 weeks after the completion of neoadjuvant therapy) |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined as the proportion of enrolled patients achieving a confirmed complete response (CR) or partial response (PR) in tumor lesions after 2 cycles of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab therapy, assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by independent radiological reviewers. ORR reflects the short-term anti-tumor efficacy of the combined neoadjuvant regimen on measurable HNSCC lesions. | Assessed at 3 to 6 weeks after the completion of neoadjuvant therapy (prior to surgical resection) |
Event-Free Survival (EFS) | Event-Free Survival (EFS) is defined as the time from the first administration of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab to the first occurrence of any study event, including radiologically or pathologically confirmed disease progression, local/distant tumor recurrence, or all-cause mortality. EFS evaluates the medium-term disease control efficacy of the combined regimen in resectable HNSCC patients. | Assessed up to 2 years after the first dose of neoadjuvant therapy (with regular follow-up every 3-4 months) |
Overall Survival (OS) | Overall Survival (OS) is defined as the time from the first administration of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab to all-cause mortality in enrolled patients. OS is a key endpoint reflecting the long-term survival benefit of the combined neoadjuvant regimen for resectable HNSCC patients, with survival status monitored through regular clinical follow-up. | Assessed up to 5 years after the first dose of neoadjuvant therapy (follow-up every 6 months for years 3-5, annually after year 5) |
Incidence and Severity of Treatment-Related Adverse Events (TRAEs) | Incidence and severity of Treatment-Related Adverse Events (TRAEs) are defined as all adverse medical events judged to be related to Sacituzumab Govitecan and/or Tagitanlimab during the entire study period, graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. This endpoint evaluates the safety and tolerability of the combined neoadjuvant regimen in resectable HNSCC patients. | Assessed from the first dose of neoadjuvant therapy to 90 days after the last study drug administration (with 30-day post-treatment safety follow-up) |
Health-Related Quality of Life (HRQoL) Assessed by EORTC QLQ-C30 | Health-Related Quality of Life (HRQoL) is evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), a validated scale measuring physical function, emotional function, social function, and symptom burden. Scores are compared at baseline and post-treatment to assess the impact of the combined neoadjuvant regimen on patients' daily functioning and well-being. | Assessed at baseline (prior to neoadjuvant therapy), post-neoadjuvant therapy (3-6 weeks), and 6/12 months after surgical resection |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Aged 18 years and above, of any gender.
- Histopathologically confirmed resectable head and neck squamous cell carcinoma (HNSCC), excluding nasopharyngeal, salivary gland, and thyroid malignant tumors; surgically assessed as resectable or potentially resectable.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Sufficient organ and bone marrow function, meeting the following: absolute neutrophil count (NEUT) ≥1.5×10⁹/L, platelet count (PLT) ≥80×10⁹/L, hemoglobin ≥8 g/dL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×upper limit of normal (ULN), total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCR) >60 mL/min; international normalized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN.
- Voluntarily participate in the study, sign the informed consent form, and be able to comply with scheduled study visits and relevant procedures in the protocol.
- A history of other malignant tumors within the past 5 years, except for cured and non-recurrent malignancies (e.g., basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ).
- Active autoimmune disease or relevant medical history (except for type 1 diabetes mellitus under stable insulin therapy), including but not limited to immune neurological diseases, systemic lupus erythematosus, inflammatory bowel disease, autoimmune hepatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome.
- A history of allergic diseases or severe drug allergy (anaphylaxis requiring hospitalization); known hypersensitivity to anti-PD-L1 antibodies, TROP2 antibody-drug conjugates (ADCs), or excipients of the study drugs.
- Prior anti-tumor treatment involving anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, TROP2 ADCs, or anti-tumor vaccine therapy.
- Receipt of a live infectious vaccine within 4 weeks prior to the first dose or planned vaccination during the study period; major surgery or severe trauma within 4 weeks prior to the first dose.
- Systemic use of corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressants within 14 days prior to the first dose (inhaled or topical steroids and adrenal replacement therapy are permitted).
- Severe medical conditions, including New York Heart Association (NYHA) class II or higher heart failure, ischemic heart disease, clinically significant arrhythmias requiring intervention, left ventricular ejection fraction (LVEF) <50% on echocardiography, or prolonged QTc interval (males >450 msec, females >470 msec).
- A known history of interstitial lung disease or high clinical suspicion of interstitial lung disease; active pulmonary tuberculosis or uncontrolled previous tuberculosis infection.
- Hyperthyroidism or organic thyroid disease (patients with hypothyroidism under stable thyroid hormone replacement therapy are eligible for enrollment).
- Active infection, unexplained fever within 48 hours prior to the first dose, or systemic antibiotic use within 1 week prior to signing the informed consent form.
- Active hepatitis B (HBV DNA ≥2000 IU/ml or ≥10⁴ copies/ml), active hepatitis C (positive anti-HCV and HCV RNA above the lower limit of detection), positive HIV antibody, or a history of acquired immunodeficiency syndrome (AIDS).
- A definite history of neurological or psychiatric diseases such as epilepsy or dementia.
- A history of drug or alcohol abuse.
- Pregnant or lactating females; patients (or their partners) planning pregnancy, having unprotected sexual intercourse, or refusing to take effective contraceptive measures during the study and for 3 months after study completion.
- Receipt of other investigational drugs within 4 weeks prior to the first dose, or concurrent participation in other interventional clinical studies (observational or follow-up interventional studies are excluded).
- Other circumstances deemed unsuitable for study participation by the investigator.
West China HospitalParte responsable del estudio
Xingchen Peng, Investigador principal, West China Hospital
Contactos centrales del estudio
Contacto: Hong-Shuai Li, Dr, +86-18384262516, [email protected]
1 Centros del estudio en 1 países
Sichuan
West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, China
Hong-Shuai Li, Contacto, +86-18384262516, [email protected]
Xing-Chen Peng, Contacto, [email protected]