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Neoadjuvant Anlotinib and Epirubicin for T4 Sinonasal Adenoid Cystic Carcinoma (NAET4-SNACC)

23 mai 2026 mis à jour par: Quan Liu, Eye & ENT Hospital of Fudan University

Neoadjuvant Anlotinib Combined With Epirubicin for T4 Stage Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Trial

T4 stage sinonasal adenoid cystic carcinoma (SNACC) is a rare but aggressive cancer in the nasal cavity and sinuses. These tumors often invade the skull base, eye socket, or brain covering (dura), making complete surgical removal difficult and carrying a high risk of recurrence even after surgery and radiation. The goal of this study is to test whether a new combination of drugs given before surgery - anlotinib (a targeted therapy) plus epirubicin (a chemotherapy drug) - can improve outcomes for patients with T4 SNACC.

This is a prospective, multicenter, single-arm, phase II clinical trial. Eligible participants will receive 2 cycles of neoadjuvant treatment (anlotinib orally for 2 weeks on/1 week off, plus epirubicin intravenously on day 1 of each 3-week cycle). After completing neoadjuvant therapy, participants will undergo surgery to remove the tumor, followed by postoperative radiotherapy. The main question the study tries to answer is whether this approach increases the 3-year progression-free survival (PFS) rate compared to the historical rate of about 70% with standard treatment (surgery plus radiotherapy alone). Secondary questions include how many tumors shrink after neoadjuvant treatment, how many operations achieve complete removal with negative margins, major pathological response rates, overall survival, safety, quality of life, and the chance of avoiding disfiguring surgeries (such as removal of the eye or part of the skull). The study will enroll about 76 participants from 5 top medical centers in China. If positive, this study may establish a new standard of care for T4 SNACC.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

Sinonasal adenoid cystic carcinoma (SNACC) is a rare cancer. T4 stage tumors often invade the skull base, orbit, or dura, making complete surgical removal difficult. Even with surgery and radiotherapy, the 3-year progression-free survival (PFS) is only about 70%, and extensive resection may cause disfigurement or loss of function.

This is a prospective, multicenter, single-arm, phase II trial. Eligible patients will receive 2 cycles of neoadjuvant therapy (anlotinib 10 mg orally on days 1-14 plus epirubicin 70 mg/m² IV on day 1, 21-day cycle). After neoadjuvant treatment, patients undergo surgery followed by postoperative radiotherapy.

The primary endpoint is 3-year PFS rate, compared with the historical rate of 70%. Secondary endpoints include objective response rate, R0 resection rate, major pathological response, overall survival, safety, quality of life, and organ preservation rate. Exploratory endpoints include biomarkers, ctDNA dynamics, and organoid drug sensitivity.

Target sample size is 76 patients from 5 Chinese centers. The study has been approved by the Institutional Review Board of Eye & ENT Hospital of Fudan University (approval number 2026069-1). Written informed consent will be obtained from all participants.

Type d'étude

Interventionnel

Inscription (Estimé)

76

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Quan Liu, MD
  • Numéro de téléphone: +86 15001959681
  • E-mail: liuqent@163.com

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100053
        • Xuanwu Hospital, Capital Medical University
        • Contact:
          • Zhenlin Wang, MD
          • Numéro de téléphone: 010-83198899 wzl1812@163.com
          • E-mail: wzl1812@163.com
    • Guangdong
      • Guangzhou, Guangdong, Chine, 510630
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
    • Shandong
      • Qingdao, Shandong, Chine, 266000
        • The Affiliated Hospital Of Qingdao University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200031
        • Eye & ENT Hospital of Fudan University
        • Contact:
          • Quan Liu, MD
          • Numéro de téléphone: +86 15001959681
          • E-mail: liuqent@163.com
      • Shanghai, Shanghai Municipality, Chine, 200030

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Age 18 to 75 years, any sex.
  • Histopathologically confirmed sinonasal adenoid cystic carcinoma (any subtype).
  • Stage T4a or T4b according to AJCC 8th edition. If lymph node metastasis is present, it must be surgically resectable. If distant metastasis is present, metastatic lesions must be stable.
  • Multidisciplinary team (MDT) assessment confirms that the tumor is technically resectable but with high risk (invasion of skull base, orbit, dura, etc.).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Adequate bone marrow, liver, kidney, and cardiac function: absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L; ALT/AST ≤2.5×upper limit of normal (ULN), total bilirubin ≤1.5×ULN; creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min; left ventricular ejection fraction (LVEF) ≥50%.
  • Willing to participate and able to provide written informed consent (including for clinical treatment and translational research).

Exclusion Criteria:

  • Prior radiotherapy to the head and neck region.
  • Prior anthracycline therapy with cumulative dose ≥300 mg/m².
  • Known hypersensitivity to any component of anlotinib or epirubicin.
  • Uncontrolled hypertension, severe cardiovascular disease, or active infection.
  • Pregnant or breastfeeding women.
  • Any medical or psychosocial condition that, in the investigator's judgment, may interfere with study compliance or conduct.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Neoadjuvant Anlotinib + Epirubicin
Participants receive neoadjuvant therapy for 2 cycles (each cycle is 21 days). Anlotinib 10 mg orally once daily on days 1-14 (2 weeks on, 1 week off). Epirubicin 70 mg/m² intravenous infusion on day 1 of each cycle. After completion of neoadjuvant therapy, participants undergo radical surgery followed by postoperative radiotherapy as per protocol.
Médicament: Anlotinib + Epirubicin
Anlotinib 10 mg orally once daily on days 1-14 of each 21-day cycle (2 weeks on, 1 week off) for 2 cycles.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
3-Year Progression-Free Survival
Délai: From enrollment to 3 years post-enrollment (assessed every 3 months for the first 2 years, then every 6 months) or until progression or death
Progression-free survival (PFS) is defined as the time from enrollment to the first documentation of disease progression (local recurrence, regional recurrence, or distant metastasis) or death from any cause, whichever occurs first. The 3-year PFS rate is the proportion of participants who remain alive and free from disease progression at 3 years after enrollment.
From enrollment to 3 years post-enrollment (assessed every 3 months for the first 2 years, then every 6 months) or until progression or death

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Objective Response Rate (ORR)
Délai: At week 6 (after completion of 2 cycles of neoadjuvant therapy, before surgery)
Proportion of participants achieving complete response (CR) or partial response (PR) after neoadjuvant therapy, assessed by RECIST v1.1 (blinded independent central review).
At week 6 (after completion of 2 cycles of neoadjuvant therapy, before surgery)
R0 Resection Rate
Délai: At time of surgery (approximately week 10-12 after enrollment)
Proportion of participants undergoing surgery who achieve microscopically negative margins (no tumor cells at the resection margin on final pathology).
At time of surgery (approximately week 10-12 after enrollment)
Overall Survival
Délai: From enrollment up to 5 years (assessed every 3 months for first 2 years, then every 6 months)
Time from enrollment to death from any cause. Participants who are alive at last follow-up will be censored.
From enrollment up to 5 years (assessed every 3 months for first 2 years, then every 6 months)
Local Control Rate
Délai: At 1 year, 2 years, and 3 years post-enrollment
Proportion of participants without local recurrence (at primary tumor site) at specified time points.
At 1 year, 2 years, and 3 years post-enrollment
Adverse events
Délai: From first dose of study drug until 30 days after last dose or surgery, whichever is later
Incidence, type, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs) assessed by CTCAE version 5.0.
From first dose of study drug until 30 days after last dose or surgery, whichever is later
EORTC QLQ-C30
Délai: Baseline, at week 6 (after neoadjuvant therapy), at 6 months, 12 months, 24 months, and 36 months post-enrollment
Change from baseline in EORTC QLQ-C30.
Baseline, at week 6 (after neoadjuvant therapy), at 6 months, 12 months, 24 months, and 36 months post-enrollment
Organ Preservation Rate
Délai: At time of surgery (approximately week 10-12 after enrollment)
Proportion of participants who avoid disfiguring surgeries including orbital exenteration, maxillectomy, craniotomy, or skull base resection compared to hypothetical initial surgery without neoadjuvant therapy.
At time of surgery (approximately week 10-12 after enrollment)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Eye & ENT Hospital of Fudan University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 juin 2028

Achèvement de l'étude (Estimé)

1 juin 2031

Dates d'inscription aux études

Première soumission

17 mai 2026

Première soumission répondant aux critères de contrôle qualité

23 mai 2026

Première publication (Réel)

1 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026069-1

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

IPD will not be shared due to concerns about participant privacy and limitations of informed consent.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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