A Study of Trastuzumab and Pyrotinib in HER2 Positive Locally Advanced or Metastatic Urothelial Carcinoma
Open-label, Single-arm Phase II Study of Trastuzumab and Pyrotinib Combination Regimen in HER2 Positive Locally Advanced or Metastatic Urothelial Carcinoma Refractory to Standard Therapies
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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Beijing、中国
- 募集
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Sign the informed consent form
- Locally advanced or metastatic histologically confirmed transitional cell carcinoma of the urothelium, including the bladder, urethra, ureter, or renal pelvis
- 18 years and older
- HER2 expression (3+ or 2+) as determined by immunohistochemistry or gene amplification by fluorescent in situ hybridization
- Relapsed from or failed at least one prior standard systemic chemotherapy regimen, including immunotherapy, HER2 ADC durgs, and chemothearpy containing cisplatin, carboplatin, paclitaxel, docetaxel, or gemcitabine
- At least 1 measurable lesion could be evaluated by RECIST v1.1
- Performance status: ECOG 0-1
- Life expectancy more than 12 weeks
- Ejection fraction at least 50% (or lower limit of normal) by echocardiogram
- Good organ function:
Blood routine: hemoglobin ≥80g/L, neutrophil ≥1.5×10^9/L, platelet ≥75×10^9/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥50ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL, ALT≤5×UNL and AST≤5×UNL for patients with liver metastasis
Exclusion Criteria:
- Have received trastuzumab or pyrotinib treatment in the past
- Known to have allergic reactions to any ingredients or excipients of experimental drugs
- Radiotherapy, RFA, interventional therapy or surgery were performed within 28 days before the first medication (except for previous diagnostic biopsy)
- Other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment
- Clinically significant ascites
- Brain metastasis or meningeal metastasis with neurological symptoms
- Diabetes was not controlled, defined as HbA1c > 7.5% after anti-diabetic drugs or hypertension was not controlled, defined as systolic / diastolic blood pressure > 140 / 90 mmHg after antihypertensive drug
- Myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) class III or IV congestive heart failure in the past 12 months
- Known to be infected with human immunodeficiency virus (HIV), have acquired immunodeficiency syndrome (AIDS) related diseases, have active hepatitis B or hepatitis C
- Pregnant or nursing
- May increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results
- There are other serious diseases that the researchers believe patients cannot be included in the study
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
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実験的：Trastuzumab + Pyrotinib
Patients receive a loading dose of trastuzumab IV over 90 minutes on day 1 of week 1. For all subsequent doses, patients receive trastuzumab IV over 30 minutes every three weeks. Meanwhile, patients also receive pyrotinib 400mg PO daily. Treatment may continue till unacceptable toxicity or disease progression occurs. |
A loading dose of trastuzumab 8mg/kg IV over 90 minutes will be administrated on day 1 of week 1. For all subsequent doses, trastuzumab 6mg/kg IV over 30 minutes will be administrated every three weeks. Pyrotinib 400mg PO daily will be administrated at the same time.
他の名前：
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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 |
|---|---|---|
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ORR
時間枠：1 year
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Objective response rate as assessed by RECIST criteria
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1 year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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OS
時間枠：From date of initiation of treatment to date of death due to any cause, assessed up to 2 years
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Overall survival
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From date of initiation of treatment to date of death due to any cause, assessed up to 2 years
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PFS
時間枠：From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 2 years
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Progression free survival
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From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 2 years
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。