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Adebrelimab Combined With Neoadjuvant Chemotherapy in Borderline Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC2501)

4 juin 2026 mis à jour par: Yang Hong, Sun Yat-sen University

Phase II Trial of Adebrelimab Combined With Nab-paclitaxel and Carboplatin for Neoadjuvant Therapy in Patients With Borderline Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

This clinical trial aims to preliminarily evaluate the efficacy and safety of adebrelimab combined with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy for borderline resectable locally advanced esophageal squamous cell carcinoma (ESCC). The primary research objectives are to increase the R0 resection rate in such patients, thereby reducing the recurrence rate and improving overall survival (OS), as well as avoiding adverse reactions associated with radiotherapy.

Aperçu de l'étude

Statut

Recrutement

Intervention / Traitement

Description détaillée

Study participants shall complete the informed consent process and undergo multidisciplinary team (MDT) review for esophageal cancer. Patients confirmed as having borderline resectable disease and meeting all inclusion/exclusion criteria will be enrolled and receive treatment with adebrelimab plus albumin-bound paclitaxel and carboplatin.

The treatment regimen is administered in 3-week cycles. Efficacy evaluation will be performed after 2 cycles:

If the disease converts to resectable status, radical surgery will be conducted.

If the disease is assessed as unresectable (progressive disease [PD] / stable disease [SD]), patients will receive definitive chemoradiotherapy or first-line treatment for advanced disease.

If partial tumor regression is observed but the tumor remains unresectable, a third treatment cycle will be administered, followed by another efficacy evaluation. If the disease becomes resectable after the third cycle, radical surgery will be performed; if still unresectable (PD/SD), definitive chemoradiotherapy or first-line treatment for advanced disease will be given.

For patients who achieve R0 resection, the investigator will determine the necessity of adjuvant therapy based on individual patient conditions. Patients with R1/R2 resection will receive concurrent chemoradiotherapy. If the MDT determines that radical resection is not feasible, patients will receive definitive concurrent chemoradiotherapy.

Type d'étude

Interventionnel

Inscription (Estimé)

42

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

Sauvegarde des contacts de l'étude

  • Nom: Chief physician
  • Numéro de téléphone: 86-13560405144

Lieux d'étude

    • Guangdong
      • Guangzhou, Guangdong, Chine, 510000
        • Recrutement
        • No. 651 Dongfeng East Road, Guangzhou
        • Contact:

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:1.Voluntarily participate in the study and sign the written informed consent form.

2.Aged between 18 and 75 years old. 3.Histologically confirmed thoracic esophageal squamous cell carcinoma without distant metastasis. Patients are defined as borderline resectable after enhanced computed tomography (CT), and/or endoscopic ultrasonography (EUS), endobronchial ultrasonography (EBUS) and multidisciplinary team (MDT) discussion.

4.No prior chemotherapy or radiotherapy. 5.Estimated overall survival of no less than 3 months. 6.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.

7.Hematological parameters (tested within 7 days): Hemoglobin (Hb) ≥ 90 g/L; Neutrophil count (NE) ≥ 1.5×10⁹/L; Platelet count (PLT) ≥ 100×10⁹/L.

8.Hepatic and renal function (tested within 7 days): Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Creatinine ≤ 1.5 × ULN; Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase (ALP) ≤ 5.0 × ULN.

9.Absence of severe complications, including active massive gastrointestinal bleeding, perforation, jaundice, intestinal obstruction, and non-neoplastic fever above 38°C.

10.Fertile patients must adopt effective contraceptive measures throughout the study period.

11.Good treatment compliance, and able to complete follow-up assessments for efficacy and adverse events as required by the protocol.

Exclusion Criteria:

  1. Patients with cervical esophageal squamous cell carcinoma.
  2. Patients with distant metastasis.
  3. Patients with nearly complete esophageal obstruction confirmed by endoscopy who require interventional therapy for decompression.
  4. Patients with prior placement of esophageal or tracheal stents.
  5. Patients with high risk of bleeding or perforation due to obvious tumor invasion into adjacent vital organs (major arteries or trachea), or patients with existing fistula formation.
  6. Patients with other concurrent primary malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
  7. Use of immunosuppressive drugs within 1 week prior to enrollment. This exclusion does not apply to intranasal, inhaled or other topical glucocorticoids, systemic glucocorticoids at physiological doses (i.e., prednisone ≤ 10 mg/day or equivalent), or glucocorticoids administered for contrast medium allergy prophylaxis.
  8. Active autoimmune diseases requiring symptomatic treatment, or a medical history of such diseases within the past 2 years.
  9. Known history of primary immunodeficiency.
  10. Confirmed active tuberculosis.
  11. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  12. Interstitial lung disease requiring corticosteroid therapy. 13Known allergy to any monoclonal antibody, chemotherapeutic agents (taxanes, carboplatin), or their excipients.

14.Severe cardiac diseases, including documented congestive heart failure, uncontrolled high-risk arrhythmia, medically treated angina pectoris, clinically significant valvular heart disease, history of severe myocardial infarction, and refractory hypertension.

15.Chronic diarrhea (≥4 watery stools per day) or renal insufficiency. 16.Active infection or active communicable diseases. 17.Neurological or psychiatric disorders impairing cognitive function. 18.Pregnant or breastfeeding women. 19.Other acute or chronic diseases, psychiatric disorders or abnormal laboratory findings that, in the investigator's judgment, may increase risks related to study participation or study drug administration, or interfere with the interpretation of study results.

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: Experimental
Adebrelimab plus nab-paclitaxel, carboplatin
Study participants shall complete the informed consent process and undergo multidisciplinary team (MDT) review for esophageal cancer. Patients confirmed as having borderline resectable disease and meeting all inclusion/exclusion criteria will be enrolled and receive treatment with adebrelimab plus albumin-bound paclitaxel and carboplatin.The treatment regimen is administered in 3-week cycles. Efficacy evaluation will be performed after 2 cycles.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
R0 resection rate
Délai: From patient enrollment to two weeks post-surgery
The proportion of patients with tumor margins showing no residual cancer cells under the microscope after surgical resection. That is, the proportion of patients in PPS achieving R0 resection.
From patient enrollment to two weeks post-surgery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall survival
Délai: up to 5 years post-surgery
OS is the time interval from the start of treatment to death due to any reason or loss of follow-up
up to 5 years post-surgery
Progression free survival
Délai: up to 5 years post-surgery
Disease free survival (DFS) refers to the time from the start of treatment until disease recurrence or death from any cause, whichever occurs first.
up to 5 years post-surgery
Pathologic complete response rate
Délai: From patient enrollment to two weeks post-surgery
From patient enrollment to two weeks post-surgery
Incidence of perioperative complications
Délai: from the first drug administration to within 30 days after the last intended treatment
from the first drug administration to within 30 days after the last intended treatment
Tumor Regression Grade
Délai: From patient enrollment to two weeks post-surgery
From patient enrollment to two weeks post-surgery

Collaborateurs et enquêteurs

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

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)

17 juin 2026

Achèvement primaire (Estimé)

1 janvier 2028

Achèvement de l'étude (Estimé)

31 janvier 2028

Dates d'inscription aux études

Première soumission

30 mai 2026

Première soumission répondant aux critères de contrôle qualité

4 juin 2026

Première publication (Réel)

10 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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

NON

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

produit fabriqué et exporté des États-Unis.

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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