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

5 de septiembre de 2021 actualizado 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.

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

204

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Shanghai
      • Shanghai, Shanghai, Porcelana, 200000
        • Shanghai Chest Hospital
        • Investigador principal:
          • Zhigang Li
        • Contacto:
          • Yang Yang

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Otros nombres:
  • carboplatino
  • 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.
Otros nombres:
  • carboplatino
  • paclitaxel
  • paclitaxel(albumin bound)
Otro: 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.
Otros nombres:
  • carboplatino
  • paclitaxel
  • paclitaxel(albumin bound)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
pCR
Periodo de tiempo: within 14 working days after surgery
pCR is defined as pathological complete response(ypT0N0)
within 14 working days after surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
OS
Periodo de tiempo: 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
Periodo de tiempo: within 14 working days after operation
defined as complete resection rate
within 14 working days after operation
EFS
Periodo de tiempo: approximately 15 months
defined as event free survival
approximately 15 months
DFS
Periodo de tiempo: approximately 15 months
defined as disease free survival
approximately 15 months
Proportion of completion of neoadjuvant treatment
Periodo de tiempo: approximately 2 months
defined as proportion of completion of neoadjuvant treatment;
approximately 2 months
Proportion of completed operations for neoadjuvant treatment
Periodo de tiempo: approximately 3 months
defined as proportion of completed operations for neoadjuvant treatment;
approximately 3 months
The proportion of patients progressing during neoadjuvant therapy;
Periodo de tiempo: approximately 2 months
defined as the proportion of patients progressing during neoadjuvant therapy;
approximately 2 months
HRQoL
Periodo de tiempo: approximately 48 months
defined as quality and nutrition assessment
approximately 48 months
AE
Periodo de tiempo: approximately 48 months
adverse events
approximately 48 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
PD-L1 expression
Periodo de tiempo: approximately 48 months
explore the correlation between the expression of PD-L1 and outcomes
approximately 48 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

14 de septiembre de 2021

Finalización primaria (Anticipado)

14 de septiembre de 2025

Finalización del estudio (Anticipado)

6 de marzo de 2026

Fechas de registro del estudio

Enviado por primera vez

5 de septiembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

5 de septiembre de 2021

Publicado por primera vez (Actual)

14 de septiembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de septiembre de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

5 de septiembre de 2021

Última verificación

1 de septiembre de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre SHR-1210

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