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El ensayo clínico NCT07459296 para Carcinoma Nasofaríngeo (CNF) 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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Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC Fase III 266 Aleatorizado Supervivencia global

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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 NCT07459296 está diseñado para estudiar el tratamiento de Carcinoma Nasofaríngeo (CNF). Es un estudio intervencionista de Fase III. Su estado actual es: reclutando. El estudio se inició el 5 de marzo de 2026, con el objetivo de reclutar a 266 participantes. Dirigido por First Affiliated Hospital of Guangxi Medical University, se espera que finalice el 1 de abril de 2032. Los datos se actualizaron por última vez en ClinicalTrials.gov el 16 de marzo de 2026.
Resumen
This study is a multicenter, randomized, controlled phase III clinical trial aiming to investigate the efficacy and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT, in the treatment of high-risk locally advanced nasopharyngeal carcinoma (LANPC)...Mostrar más
Descripción detallada
This is a multicenter, randomized, controlled phase III clinical study targeting patients with high-risk locally advanced nasopharyngeal carcinoma (stage T1-4N2-3M0 or T4N1M0 per the 9th AJCC/UICC staging system), with a planned enrollment of 266 patients who will be randomized 1:1 into an experimental group and a control group under an open-label, stratified randomization design. The primary endpoint of the study is...Mostrar más
Título oficial

Becotatug Vedotin Combined With Sintilimab and Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：A Multicenter, Randomized, Controlled, Phase 3 Trial

Condiciones médicas
Carcinoma Nasofaríngeo (CNF)
Otros ID del estudio
  • 2026-K0013
Número del NCT
NCT07459296
Inicio del estudio (real)
2026-03-05
Última actualización
2026-03-16
Fecha de finalización (estimada)
2032-04-01
Inscripción (prevista)
266
Tipo de estudio
Intervencionista
FASE
Fase III
Estado general
Reclutando
Palabras clave
Nasopharyngeal Carcinoma
Becotatug Vedotin
Sintilimab
Concurrent Chemoradiotherapy
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalBecotatug Vedotin followed by CCRT plus Sintilimab
Patients will receive Becotatug Vedotin induction therapy followed by CCRT combined with neoadjuvant and adjuvant sintilimab
Becotatug Vedotin
Becotatug vedotin 2.3 mg/kg will be given on Day 1 of induction therapy, once every 3 weeks for a total of 3 cycles.
Sintilimab
In the induction treatment phase, sintilimab 200 mg will be administered on Day 1 of each induction cycle, once every 3 weeks, for a total of 3 cycles. In the adjuvant treatment phase, sintilimab 200 mg will be given on Day 1, initiated 3 weeks after the completion of radiotherapy, once every 3 weeks, for a total of 9 cycles.
Cisplatin
Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
Radioterapia de intensidad modulada
Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions
Comparador activoInduction Chemotherapy followed by CCRT
Patients will receive gemcitabine plus cisplatin induction chemotherapy followed by CCRT
Cisplatin
Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
Radioterapia de intensidad modulada
Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions
Gemcitabine (GEM)
Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.
Cisplatin
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Event-free survival (EFS)
The time interval from randomization to the first treatment failure or the last follow-up if there is no treatment failure. Treatment failure is defined as local/cervical residual disease 16 weeks after radiotherapy, local/cervical recurrence, distant metastasis, or death due to any cause,whichever occurred first.
3 years
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Overall survival (OS)
The time interval from randomization to the date of death from any cause.
3 years
Distant metastasis-free survival (DMFS)
The time interval from randomization to the date of first distant metastasis, or death from any cause, whichever occurred first.
3 years
Locoregional recurrence-free survival (LRFS)
The time interval randomization to the date of locoregional persistence, 1st locoregional recurrence, or death from any cause, whichever occurred first.
3 years
Adverse events (AEs) and serious adverse events (SAEs)
Graded according to CTCAE V5.0.
3 years
Quality of life (QoL)
The change of QoL from randomization to the start of radiotherapy,the 16th fraction of radiotherapy, the end of radiotherapy, 43 weeks (at the end of sintilimab treatment in the sintilimab arm and the corresponding timepoint in the chemoradiation arm). The EORTC QoL questionnaire-C30 (EORTC QLQ-C30）version 3.0 will be used. This questionnaire comprises 30 questions, 24 of which are aggregated into nine multi-question scales, that is, five functioning scales (e.g., physical), three symptom scales (e.g., fatigue) and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual.
3 years
Event-free survival (EFS) within different subgroups
analyses for EFS will be performed within the following subgroups: Epstein-Barr virus (EBV) DNA (\<4000copies/ml vs. ≥4000copies/ml), EGFR expression status (positive vs negative), different PD-L1 expression levels (\<1% vs. ≥1%), tertiary lymphoid structure (+ vs. -), age, gender, performance status, T category, N category, and stage (II vs. III).
3 years
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  1. Voluntarily participate in the study and sign the informed consent form in writing.
  2. Aged 18-70 years, male or non-pregnant female.
  3. Pathologically confirmed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III).
  4. Staged as anyT N2-3 or T4N1 (9th AJCC/UICC staging) without distant metastasis.
  5. ECOG performance status score of 0-1.
  6. Hemoglobin (HGB) ≥ 90 g/L, neutrophil count ≥ 1.5×10⁹/L, and platelet (PLT) count ≥ 100×10⁹/L.
  7. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), and total bilirubin ≤ 1.5 times ULN.
  8. Normal renal function: Creatinine clearance rate ≥ 60 ml/min (calculated using the Cockcroft-Gault formula).
  9. Sexually active females of childbearing potential must agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug. Males who have sexual relations with females of childbearing potential must also agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug.

  1. Aged > 70 years or < 18 years.
  2. Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
  3. Pathologically confirmed as keratinizing squamous cell carcinoma (WHO type I).
  4. Patients who have previously received radiotherapy or systemic chemotherapy.
  5. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA > 1000 copies/mL or 200 IU/mL.
  6. Positive for hepatitis C virus antibody (anti-HCV).
  7. Patients with active autoimmune diseases, excluding type 1 diabetes mellitus, hypothyroidism controlled by replacement therapy, and skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
  8. Patients who received systemic glucocorticoids (equivalent to prednisone > 10 mg/day) or other immunosuppressive therapy within 28 days prior to signing the informed consent form. Patients who received systemic glucocorticoids equivalent to prednisone ≤ 10 mg/day, inhaled or topical glucocorticoids are eligible for enrollment.
  9. Patients with a history of active tuberculosis within the past year; patients with active tuberculosis that has been adequately treated for more than one year are eligible for enrollment. Patients with a history of other malignant tumors (except cured basal cell carcinoma or carcinoma in situ of the cervix).
  10. Patients with a history of interstitial lung disease.
  11. Patients who received live vaccines within 30 days prior to signing the informed consent form or plan to receive live vaccines in the near future.
  12. Pregnant or lactating females.
  13. Patients with a history of other malignant tumors within the past 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer.
  14. Patients with known hypersensitivity to any component of gemcitabine, cisplatin, becotatug vedotin, or sintilimab.
  15. Patients with known history of HIV infection.
  16. Any other conditions deemed by the investigator to potentially affect the patient's ability to sign the informed consent form, cooperate with and participate in the study, or interfere with the interpretation of results, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infections requiring systemic treatment, mental illnesses, or family/social factors.
First Affiliated Hospital of Guangxi Medical University logoFirst Affiliated Hospital of Guangxi Medical University
Contactos centrales del estudio
Contacto: Min Kang, MD, +86-771-5356509, [email protected]
1 Centros del estudio en 1 países

Guangxi

The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China
Min Kang, MD, Contacto, +86-771-5356509, [email protected]
Reclutando