このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2021年9月5日 更新者: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.

調査の概要

状態

まだ募集していません

介入・治療

研究の種類

介入

入学 (予想される)

204

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Shanghai
      • Shanghai、Shanghai、中国、200000
        • Shanghai Chest Hospital
        • 主任研究者:
          • Zhigang Li
        • コンタクト:
          • Yang Yang

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
他の名前:
  • カルボプラチン
  • パクリタキセル
  • paclitaxel(albumin bound)
実験的: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.
他の名前:
  • カルボプラチン
  • パクリタキセル
  • paclitaxel(albumin bound)
他の: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.
他の名前:
  • カルボプラチン
  • パクリタキセル
  • paclitaxel(albumin bound)

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
pCR
時間枠:within 14 working days after surgery
pCR is defined as pathological complete response(ypT0N0)
within 14 working days after surgery

二次結果の測定

結果測定
メジャーの説明
時間枠
OS
時間枠: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
時間枠:within 14 working days after operation
defined as complete resection rate
within 14 working days after operation
EFS
時間枠:approximately 15 months
defined as event free survival
approximately 15 months
DFS
時間枠:approximately 15 months
defined as disease free survival
approximately 15 months
Proportion of completion of neoadjuvant treatment
時間枠:approximately 2 months
defined as proportion of completion of neoadjuvant treatment;
approximately 2 months
Proportion of completed operations for neoadjuvant treatment
時間枠:approximately 3 months
defined as proportion of completed operations for neoadjuvant treatment;
approximately 3 months
The proportion of patients progressing during neoadjuvant therapy;
時間枠:approximately 2 months
defined as the proportion of patients progressing during neoadjuvant therapy;
approximately 2 months
HRQoL
時間枠:approximately 48 months
defined as quality and nutrition assessment
approximately 48 months
AE
時間枠:approximately 48 months
adverse events
approximately 48 months

その他の成果指標

結果測定
メジャーの説明
時間枠
PD-L1 expression
時間枠:approximately 48 months
explore the correlation between the expression of PD-L1 and outcomes
approximately 48 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2021年9月14日

一次修了 (予想される)

2025年9月14日

研究の完了 (予想される)

2026年3月6日

試験登録日

最初に提出

2021年9月5日

QC基準を満たした最初の提出物

2021年9月5日

最初の投稿 (実際)

2021年9月14日

学習記録の更新

投稿された最後の更新 (実際)

2021年9月14日

QC基準を満たした最後の更新が送信されました

2021年9月5日

最終確認日

2021年9月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

SHR-1210の臨床試験

3
購読する