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A Trial Of Neoadjuvant Chemotherapy or Radiochemotherapy With Or Without SHR-1210 In Patients With Resectable ESCC.

5 de setembro de 2021 atualizado por: Zhigang Li

A Trial Of Neoadjuvant Chemotherapy or Radiochemotherapy With Or Without SHR-1210 In Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma.This is a Randomised, Open, Parallel Control, Multi-center Phase II Trial.

The purpose of this study is to explore the effectiveness and safety of neoadjuvant immune combined chemotherapy or radiochemotherapy compared with traditional neoadjuvant radiochemotherapy in patients with locally advanced Esophageal Squamous Cell Carcinoma.

Visão geral do estudo

Status

Ainda não está recrutando

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Antecipado)

204

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

Locais de estudo

    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Shanghai Chest Hospital
        • Investigador principal:
          • Zhigang Li
        • Contato:
          • Yang Yang

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

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. The result of pathological biopsy showed esophageal squamous cell carcinoma;
  2. Have not received systemic or local treatment for esophageal cancer in the past;
  3. Age 18-75 years (including 18 and 75 years old), both male and female;
  4. ECOG score 0-1;
  5. Thoracic esophageal cancer assessed by CT/MRI/EUS etc. as resectable and the clinical stage is T1b-3N1-3M0 or T3N0M0, according to the 8th edition of AJCC staging;
  6. Those who are expected to achieve R0 resection;
  7. Voluntarily sign an informed consent form before treatment;
  8. Plan to receive surgical treatment after neoadjuvant treatment is completed;
  9. No surgical contraindications;
  10. Normal function of major organs
  11. Female subjects with fertility must undergo a serum pregnancy test within 72 hours before starting the study drug administration, and the result is negative, and take effective contraception during the trial and at least 3 months after the last administration Measures (such as intrauterine devices, contraceptives, or condoms); for male subjects whose partners are females of childbearing age, effective contraceptive measures should be taken during the trial and within 3 months after the last administration;
  12. The subjects have good compliance and can follow up the efficacy and adverse events/reactions according to the requirements of the plan;

Exclusion Criteria:

  1. There are unresectable factors, including unresectable tumors, unresectable contraindications for surgery, or rejection of surgery;
  2. Patients with supraclavicular lymph node metastasis;
  3. Poor nutritional status, BMI <18.5 Kg/m2; if the symptomatic nutritional support is corrected before randomization, the main investigator can continue to consider it after evaluation;
  4. Those who are known to have a history of allergies to the drug components of this program;
  5. Have received or are receiving any of the following treatments in the past:

    1. Any radiotherapy, chemotherapy or other anti-tumor drugs for tumors;
    2. Immunosuppressive drugs or systemic hormone drugs are being used within 2 weeks before the first use of the study drug to achieve immunosuppressive purposes (dose>10mg/day prednisone or equivalent dose); if there is no active autoimmune disease In the case of inhalation or topical use of steroids and prednisone doses> 10 mg/day or equivalent doses of adrenal cortex hormone replacement are allowed;
    3. Received a live attenuated vaccine within 4 weeks before using the study drug for the first time;
    4. Have undergone major surgery or severe trauma within 4 weeks before using the study drug for the first time;
  6. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;
  7. There are clinical symptoms or diseases of the heart that are not well controlled;
  8. Severe infections (CTCAE v5.0> level 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infectious comorbidities that require hospitalization, etc.; baseline chest imaging examinations suggest activity Pulmonary inflammation, symptoms and signs of infection in the 14 days before the first use of the study drug, or those who require oral or intravenous antibiotic treatment, except for the prophylactic use of antibiotics;
  9. Participated in other drug clinical studies within 4 weeks before randomization;
  10. People who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease that requires hormone therapy, or have other pulmonary fibrosis that may interfere with the judgment and management of immune-related lung toxicity , Organizing pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects whose CT shows active pneumonia or severe lung dysfunction during the screening period; active tuberculosis;
  11. Patients with any active autoimmune diseases or history of autoimmune diseases with the possibility of recurrence; patients with skin diseases that do not require systemic treatment, such as leukoplakia, psoriasis, hair loss, and insulin treatment Patients with controllable type I diabetes or a history of asthma, but who have been completely relieved during childhood without any intervention can be included in the group; patients with asthma who need bronchodilator intervention cannot be included in the group;
  12. There is active hepatitis B (HBV-DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the lower limit of the analytical method);
  13. Other malignant tumors have been diagnosed within 5 years before the first use of the study drug, unless malignant tumors with low risk of metastasis or death (5-year survival rate> 90%), such as fully treated skin basal cell carcinoma or squamous cell Skin cancer or cervical carcinoma in situ, etc., may be considered for inclusion;
  14. Women who are pregnant or breastfeeding;
  15. According to the judgment of the investigator, there are other factors that may lead to the forced termination of the study, such as suffering from other serious diseases (including mental illness) requiring combined treatment, alcoholism, drug abuse, family or social factors, which may affect the subjects Factors of safety or compliance.

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: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Neoadjuvant Chemotherapy With SHR-1210

Neoadjuvant Chemotherapy: Paclitaxel(Albumin Bound)100mg/m2, Day 1,8,15,Carboplatin AUC=5mg/ml/min,Day 1,SHR-1210 200mg,Day 1,every 3 weeks, 2 cycles.

Postoperative adjuvant treatment:SHR-1210 maintenance

The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: immunotherapy combined with neoadjuvant chemotherapy, immunotherapy combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy.
Outros nomes:
  • carboplatina
  • paclitaxel
  • paclitaxel(albumin bound)
Experimental: Neoadjuvant Radiochemotherapy With SHR-1210

Neoadjuvant Radiochemotherapy: Paclitaxel 50mg/m2, Day 1,8,15,22,29,Carboplatin AUC=2mg/ml/min,Day 1,8,15,22,29,SHR-1210 200mg,Day 1,22, 5 cycles.

Radio therapy d1-23. Postoperative adjuvant treatment:SHR-1210 maintenance

The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: immunotherapy combined with neoadjuvant chemotherapy, immunotherapy combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy.
Outros nomes:
  • carboplatina
  • paclitaxel
  • paclitaxel(albumin bound)
Outro: Neoadjuvant Radiochemotherapy Without SHR-1210

Neoadjuvant Radiochemotherapy: Paclitaxel 50mg/m2, Day 1,8,15,22,29,Carboplatin AUC=2mg/ml/min,Day 1,8,15,22,29, 5 cycles.

Radio therapy d1-23. Postoperative adjuvant treatment:according to the recommendations of the guidelines and the investigators

The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: immunotherapy combined with neoadjuvant chemotherapy, immunotherapy combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy.
Outros nomes:
  • carboplatina
  • paclitaxel
  • paclitaxel(albumin bound)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
pCR
Prazo: within 14 working days after surgery
pCR is defined as pathological complete response(ypT0N0)
within 14 working days after surgery

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
OS
Prazo: approximately 22 months
OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier
approximately 22 months
R0 resection rate
Prazo: within 14 working days after operation
defined as complete resection rate
within 14 working days after operation
EFS
Prazo: approximately 15 months
defined as event free survival
approximately 15 months
DFS
Prazo: approximately 15 months
defined as disease free survival
approximately 15 months
Proportion of completion of neoadjuvant treatment
Prazo: approximately 2 months
defined as proportion of completion of neoadjuvant treatment;
approximately 2 months
Proportion of completed operations for neoadjuvant treatment
Prazo: approximately 3 months
defined as proportion of completed operations for neoadjuvant treatment;
approximately 3 months
The proportion of patients progressing during neoadjuvant therapy;
Prazo: approximately 2 months
defined as the proportion of patients progressing during neoadjuvant therapy;
approximately 2 months
HRQoL
Prazo: approximately 48 months
defined as quality and nutrition assessment
approximately 48 months
AE
Prazo: approximately 48 months
adverse events
approximately 48 months

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
PD-L1 expression
Prazo: approximately 48 months
explore the correlation between the expression of PD-L1 and outcomes
approximately 48 months

Colaboradores e Investigadores

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

Patrocinador

Publicações e links úteis

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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 (Antecipado)

14 de setembro de 2021

Conclusão Primária (Antecipado)

14 de setembro de 2025

Conclusão do estudo (Antecipado)

6 de março de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

5 de setembro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de setembro de 2021

Primeira postagem (Real)

14 de setembro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de setembro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de setembro de 2021

Última verificação

1 de setembro de 2021

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

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 .

Ensaios clínicos em SHR-1210

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