ベータ
治験レーダーAI
治験 NCT05791136 (TREE)（対象：AJCC V8ステージによる食道扁平上皮癌）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
フィルター基準に一致する試験が1件見つかりました
タイル表示
検索に戻る

Immunotherapy After Radiotherapy in Elderly ESCC (TREE) 第II相・フェーズ2 30 免疫療法 高齢者

募集準備中
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05791136 (TREE) は 治療 の研究で、AJCC V8ステージによる食道扁平上皮癌 に関するものです。この 第II相・フェーズ2 介入研究 臨床試験 は現在 募集準備中 で、2023年4月1日 に開始予定です。30 名の参加者 の募集が計画されています。この試験は The Central Hospital of Lishui City によって主導され、2026年6月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2023年3月30日 です。
概要
The incidence and mortality of esophageal squamous cell carcinoma are at the forefront in China.Most part of patients are elderly. Concurrent chemoradiotherapy is the standard treatment for unresectable locally advanced esophageal squamous cell carcinoma. Most elderly patients cannot tolerate concurrent chemotherapy because of complications and other reasons. Immunotherapy has definite efficacy and low toxicity in ad...もっと見る
詳細説明
This is a prospective, multicenter, single-arm, phase Ⅱ clinical study to evaluate the efficacy and safety of radiotherapy alone followed by sequential injection of Toripalimab in elderly patients with unresectable esophageal squamous cell carcinoma who could not accept concurrent chemotherapy.
公式タイトル

Toripalimab After Radiotherapy Alone in Elderly Esophageal Squamous Cell Carcinoma: A Prospective Phase II Clinical Trial

疾患名
AJCC V8ステージによる食道扁平上皮癌
その他の研究識別子
  • TREE
  • ZJLSRT-001
NCT番号
NCT05791136
開始日
2023-04
最終更新日
2023-03-30
終了予定日
2026-06-30
目標参加者数
30
試験の種類
介入研究
治験の相・段階
第II相・フェーズ2
状況
募集準備中
キーワード
Esophageal Squamous Cell Carcinoma
PD-1
Elderly
Radiotherapy
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
参加グループ/群介入/治療法
実験的Radiotherapy Sequential Toripalimab
Radiotherapy:Intensity-modulated radiotherapy (IMRT) Immunotherapy: Toripalimab
放射線治療
95% PGTV56-60Gy/28-30 fractions, 2Gy/1 fractions; 95% PTV50.4-54Gy/28-30 fractions, 1.8Gy/1 fractions; 5 days a week; 6 weeks.
Toripalimab
Toripalimab (200 mg, intravenously infused) will be administered as the maintenance treatment every 3 weeks within 4 weeks after the completion of radiotherapy for 1 years or until progression, intolerable toxicity, or physician/patient decision
主要評価項目
評価指標指標の説明時間枠
Progression-free survival (PFS)
We aim to evaluate the progression-free survival (PFS) of elderly patients with unresectable esophageal squamous cell carcinoma who were unable to accept concurrent chemotherapy and received sequential treatment with Triptolide injection after radiotherapy alone.
2 years
副次評価項目
評価指標指標の説明時間枠
Overall survival (OS)
Overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence .
2 years
Objective response rate (ORR)
Objective response rate (ORR) is defined as the proportion of patients with a complete response(CR) or partial response(PR) to treatment according to RECIST v1.1.
2 years
Duration of response (DOR)
Duration of response (DOR) was determined from date of initial response to PD according to RECIST v1.1.
2 years
Time to death or distant metastasis (TTDM)
Time to death or distant metastasis (TTDM) according to RECIST v1.1.
2 years
参加アシスタント
適格基準

対象年齢
高齢者
試験の最低年齢
75 Years
対象性別
全て
  1. Age ≥75 years old, regardless of gender；
  2. Esophageal cancer confirmed by histology or cytology；
  3. Unresectable, unable to tolerate or refuse surgery and concurrent chemoradiotherapy；
  4. Unable to tolerate chemotherapy；
  5. There are at least one lesions measurable according to RECIST 1.1；
  6. Stage II-iva (AJCC 8 TNM classification)
  7. Endoscopic ultrasonography confirmed that esophageal lesions did not invade adjacent organs (T1-4a).；
  8. ECOG PS 0-1；
  9. Forced expiratory volume (FEV) >0.8 liter；
  10. Life expectancy of at least 12 weeks；
  11. Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, biotherapy，etc.
  12. Has sufficient organ function： (1) Blood routine: ANC≥1.5×109/L; PLT≥50×109/L; HGB≥90 g/L((No blood transfusion and blood products within 14 days, no use of G-CSF and other blood-stimulating factors to correct)) (2) Liver function: TBIL ≤ 1.5 × ULN，ALT、AST ≤2.5 × ULN， (3) Renal function: Cr≤1×ULN or crcl ≥50 ml/min (4) Adequate haemostasis laboratory data prior to randomization: INR or PT ≤1.5×ULN (If the subject was receiving anticoagulant therapy, as long as the PT was within the intended use range of anticoagulant drugs) (5) Myocardial enzymes were within the normal range.
  13. Patients voluntarily joined this study, signed informed consent and provided diagnosis and treatment data after cancer diagnosis before entering the group, good compliance, and cooperation with follow-up visits;

  1. Synchronous or metachronous second primary malignancy. Participants with basal cell carcinoma of the skin, or cervical cancer in situ that have undergone potentially curative therapy are not excluded from the study;
  2. with multifocal primary esophageal cancer;
  3. The pathological diagnosis was esophageal small cell carcinoma, adenocarcinoma, or mixed carcinoma.
  4. Esophageal squamous cell carcinoma with active bleeding within 2 months of the primary lesion；
  5. Patients whose imaging has shown that the tumor has invaded the important blood vessels or the investigator judges that the tumor is likely to invade the important blood vessels and cause fatal hemorrhage during the follow-up study
  6. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, glomerulonephritis, thyroiditis (patients with vitiligo or asthma has been completely relieved in childhood, and do not need any intervention during adulthood can be included; patients with type I diabetes with good insulin control can also be included; hypothyroidism caused by autoimmune thyroiditis requiring hormone replacement therapy can also be included)
  7. Clinically significant cardiac disease or impaired cardiac function, such as: MeanQT interval corrected for heart rate (QTc) ≥470 ms, Congestive heart failure requiring treatment (New York Heart Association \[NYHA\] grade > 2), left ventricular ejection fraction (LVEF) <50% as determined by Echocardiography.
  8. Active infection or fever of unknown origin > 38.5 ° C during screening or before the first dose (tumor-related fever, as judged by the investigator, was eligible);
  9. Current pneumonitis or interstitial lung disease or history of pneumonitis or interstitial lung disease.
  10. Has had congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 104 copies/ml) or hepatitis C (HCR-RNA was higher than the detection limit of the analytical method);
  11. Previous treatment with another PD-1, PD-L1；
  12. Known hypersensitivity to macromolecular protein preparations or to any anti-PD-1 antibody component;；
  13. Immunosuppressive drugs used within 7 days prior to the initial study treatment, excluding local glucocorticoids, or systemic glucocorticoids at physiological doses (i.e., no more than 10 mg/ day of prednisone or equivalent doses of other glucocorticoids); Systemic steroid doses of less than 10 mg of prednisone daily or its equivalent are allowed in patients receiving physiologic replacement steroid doses without autoimmune disease.
  14. if they had undergone major surgery patients must have fully recovered from surgery with no major ongoing safety issues before the experiment begins.
  15. Currently participating in an interventional clinical research treatment, or has received another investigational drug or used an investigational device within 4 weeks prior to the first administration of the drug.
  16. Live vaccine within 4 weeks prior to first dose (Cycle 1, Day 1); NOTE: Injectable inactivated viral vaccine against seasonal influenza is allowed; however, live attenuated influenza vaccine for intranasal administration is not allowed.
  17. The investigator considers it unsuitable for inclusion. Patients with uncontrollable seizures or loss of self-control due to mental illness. serious abnormal laboratory test results, family, or social factors, which may affect the safety of the subjects or the data collection.
The Central Hospital of Lishui City logoThe Central Hospital of Lishui City
試験中央連絡先
連絡先: Zhifeng Tian, M.D, 0578-2285350, [email protected]
連絡先: Wencai Li, M.D, 0578-2285250, [email protected]
位置情報がありません。