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

5 septembre 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

204

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

Lieux d'étude

    • Shanghai
      • Shanghai, Shanghai, Chine, 200000
        • Shanghai Chest Hospital
        • Chercheur principal:
          • Zhigang Li
        • Contact:
          • Yang Yang

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

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 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: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autres noms:
  • carboplatine
  • paclitaxel
  • paclitaxel(albumin bound)
Expérimental: 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.
Autres noms:
  • carboplatine
  • paclitaxel
  • paclitaxel(albumin bound)
Autre: 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.
Autres noms:
  • carboplatine
  • paclitaxel
  • paclitaxel(albumin bound)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
pCR
Délai: within 14 working days after surgery
pCR is defined as pathological complete response(ypT0N0)
within 14 working days after surgery

Mesures de résultats secondaires

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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
PD-L1 expression
Délai: approximately 48 months
explore the correlation between the expression of PD-L1 and outcomes
approximately 48 months

Collaborateurs et enquêteurs

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

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.

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 (Anticipé)

14 septembre 2021

Achèvement primaire (Anticipé)

14 septembre 2025

Achèvement de l'étude (Anticipé)

6 mars 2026

Dates d'inscription aux études

Première soumission

5 septembre 2021

Première soumission répondant aux critères de contrôle qualité

5 septembre 2021

Première publication (Réel)

14 septembre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 septembre 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 septembre 2021

Dernière vérification

1 septembre 2021

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

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 .

Essais cliniques sur SHR-1210

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