Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

4 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

42

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

  • Nome: Chief physician
  • Número de telefone: 86-13560405144

Locais de estudo

    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recrutamento
        • No. 651 Dongfeng East Road, Guangzhou
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
R0 resection rate
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall survival
Prazo: 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
Prazo: 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
Prazo: From patient enrollment to two weeks post-surgery
From patient enrollment to two weeks post-surgery
Incidence of perioperative complications
Prazo: 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
Prazo: From patient enrollment to two weeks post-surgery
From patient enrollment to two weeks post-surgery

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

17 de junho de 2026

Conclusão Primária (Estimado)

1 de janeiro de 2028

Conclusão do estudo (Estimado)

31 de janeiro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

30 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de junho de 2026

Primeira postagem (Real)

10 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever