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UMIN-CTR 臨床試験登録情報の閲覧 |
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利用者名: | UMIN ID: |
試験進捗状況 | 開始前/Preinitiation |
UMIN試験ID | UMIN000046751 |
受付番号 | R000053339 |
科学的試験名 | durvalumab + tremelimumab併用療法による副作用 |
一般公開日(本登録希望日) | 2022/01/27 |
最終更新日 | 2022/01/27 |
基本情報/Basic information | |||
一般向け試験名/Public title | durvalumab + tremelimumab併用療法による副作用 | Adverse events frequency caused by durvalumab and tremelimumab combination therapy: meta-analysis | |
一般向け試験名略称/Acronym | durvalumab + tremelimumab併用療法による副作用 | Adverse events frequency caused by durvalumab and tremelimumab combination therapy: meta-analysis | |
科学的試験名/Scientific Title | durvalumab + tremelimumab併用療法による副作用 | Adverse events frequency caused by durvalumab and tremelimumab combination therapy: meta-analysis | |
科学的試験名略称/Scientific Title:Acronym | durvalumab + tremelimumab併用療法による副作用 | Adverse events frequency caused by durvalumab and tremelimumab combination therapy: meta-analysis | |
試験実施地域/Region |
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対象疾患/Condition | |||
対象疾患名/Condition | 癌 | malignancies | |
疾患区分1/Classification by specialty |
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疾患区分2/Classification by malignancy | 悪性腫瘍/Malignancy | ||
ゲノム情報の取扱い/Genomic information | いいえ/NO |
目的/Objectives | ||
目的1/Narrative objectives1 | 英文参照 | Numbers of clinical trials evaluated dual ICI therapy, durvalumab and tremelimumab combination. Although the safety profiles of durvalumab and tremelimumab have been reported in individual clinical trials, it is difficult to scrutinize frequencies of rare critical AEs using data of an individual trial. An increasing number of clinical studies on durvalumab and tremelimumab have been reported in particular since 2020, and there is a growing demand for accurate information on the AE caused by durvalumab and tremelimumab. Our systematic review was designed to assess per-person frequencies of AEs caused by durvalumab and tremelimumab administered for patients with malignancies. |
目的2/Basic objectives2 | 安全性/Safety | |
目的2 -その他詳細/Basic objectives -Others | ||
試験の性質1/Trial characteristics_1 | ||
試験の性質2/Trial characteristics_2 | ||
試験のフェーズ/Developmental phase |
評価/Assessment | ||
主要アウトカム評価項目/Primary outcomes | 副作用頻度 | Frequencies of AEs. |
副次アウトカム評価項目/Key secondary outcomes |
基本事項/Base | ||
試験の種類/Study type | その他・メタアナリシス等/Others,meta-analysis etc |
試験デザイン/Study design | ||
基本デザイン/Basic design | ||
ランダム化/Randomization | ||
ランダム化の単位/Randomization unit | ||
ブラインド化/Blinding | ||
コントロール/Control | ||
層別化/Stratification | ||
動的割付/Dynamic allocation | ||
試験実施施設の考慮/Institution consideration | ||
ブロック化/Blocking | ||
割付コードを知る方法/Concealment |
介入/Intervention | ||
群数/No. of arms | ||
介入の目的/Purpose of intervention | ||
介入の種類/Type of intervention | ||
介入1/Interventions/Control_1 | ||
介入2/Interventions/Control_2 | ||
介入3/Interventions/Control_3 | ||
介入4/Interventions/Control_4 | ||
介入5/Interventions/Control_5 | ||
介入6/Interventions/Control_6 | ||
介入7/Interventions/Control_7 | ||
介入8/Interventions/Control_8 | ||
介入9/Interventions/Control_9 | ||
介入10/Interventions/Control_10 |
適格性/Eligibility | |||||
年齢(下限)/Age-lower limit |
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年齢(上限)/Age-upper limit |
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性別/Gender | 男女両方/Male and Female | ||||
選択基準/Key inclusion criteria | 英文参照 | Patients with any malignancies who were treated with combined D+T are patients of interests. We will not question cancer type because our analysis will focus on AE but not efficacy.
We will collected AE data of D+T regimen regardless of dose, scheduling, maintenance therapy, and planned number of doses. Perioperative chemotherapy including both adjuvant and neoadjuvant treatment will be accepted. |
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除外基準/Key exclusion criteria | 英文参照 | Concurrent and sequential chemoradiotherapies will be excluded because anti-cancer drug dosage and safety profile are greatly deviated from D+T alone. Besides, regimen with three or more anti-cancer agents will not be allowed. Consequent treatment of D and T, for example, four doses of D followed by maintenance T, was excluded. | |||
目標参加者数/Target sample size |
責任研究者/Research contact person | ||||||||||||||
責任研究者/Name of lead principal investigator |
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所属組織/Organization | 横浜市立大学附属病院 | Yokohama City University hospital | ||||||||||||
所属部署/Division name | 化学療法センター | Chemotherapy Center | ||||||||||||
郵便番号/Zip code | 236-0004 | |||||||||||||
住所/Address | 横浜市金沢区福浦3-9 | 3-9, Fukuura, Kanazawa, Yokohama | ||||||||||||
電話/TEL | +810081457872800 | |||||||||||||
Email/Email | horitano@yokohama-cu.ac.jp |
試験問い合わせ窓口/Public contact | ||||||||||||||
試験問い合わせ窓口担当者/Name of contact person |
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組織名/Organization | 横浜市立大学附属病院 | Yokohama City University Hospital | ||||||||||||
部署名/Division name | 化学療法センター | Chemotherapy Center | ||||||||||||
郵便番号/Zip code | 236-0004 | |||||||||||||
住所/Address | 横浜市金沢区福浦3-9 | 3-9, Fukuura, Kanazawa, Yokohama | ||||||||||||
電話/TEL | +810081457872800 | |||||||||||||
試験のホームページURL/Homepage URL | ||||||||||||||
Email/Email | horitano@yokohama-cu.ac.jp |
実施責任組織/Sponsor | ||
機関名/Institute | その他 | Yokohama City University hospital |
機関名/Institute (機関選択不可の場合) |
横浜市立大学附属病院 | |
部署名/Department |
研究費提供組織/Funding Source | ||
機関名/Organization | 自己調達 | Yokohama City University hospital |
機関名/Organization (機関選択不可の場合) |
横浜市立大学附属病院 | |
組織名/Division | 横浜市立大学附属病院 | |
組織の区分/Category of Funding Organization | 自己調達/Self funding | |
研究費拠出国/Nationality of Funding Organization |
その他の関連組織/Other related organizations | ||
共同実施組織/Co-sponsor | ||
その他の研究費提供組織/Name of secondary funder(s) |
IRB等連絡先(公開)/IRB Contact (For public release) | ||
組織名/Organization | 横浜市立大学附属病院 | Yokohama City University Hospital |
住所/Address | 横浜市金沢区福浦3-9 | 3-9, Fukuura, Kanazawa, Yokohama |
電話/Tel | +810081457872800 | |
Email/Email | horitano@yokohama-cu.ac.jp |
他機関から発行された試験ID/Secondary IDs | ||
他機関から発行された試験ID/Secondary IDs | いいえ/NO | |
試験ID1/Study ID_1 | ||
ID発行機関1/Org. issuing International ID_1 | ||
試験ID2/Study ID_2 | ||
ID発行機関2/Org. issuing International ID_2 | ||
治験届/IND to MHLW |
試験実施施設/Institutions | ||
試験実施施設名称/Institutions |
その他の管理情報/Other administrative information | ||||||||
一般公開日(本登録希望日)/Date of disclosure of the study information |
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関連情報/Related information | ||
プロトコル掲載URL/URL releasing protocol | ||
試験結果の公開状況/Publication of results | 未公表/Unpublished |
結果/Result | ||
結果掲載URL/URL related to results and publications | ||
組み入れ参加者数/Number of participants that the trial has enrolled | ||
主な結果/Results | ||
主な結果入力日/Results date posted | ||
結果掲載遅延/Results Delayed | ||
結果遅延理由/Results Delay Reason | ||
最初の試験結果の出版日/Date of the first journal publication of results | ||
参加者背景/Baseline Characteristics | ||
参加者の流れ/Participant flow | ||
有害事象/Adverse events | ||
評価項目/Outcome measures | ||
個別症例データ共有計画/Plan to share IPD | ||
個別症例データ共有計画の詳細/IPD sharing Plan description |
試験進捗状況/Progress | ||||||||
試験進捗状況/Recruitment status | 開始前/Preinitiation | |||||||
プロトコル確定日/Date of protocol fixation |
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倫理委員会による承認日/Date of IRB | ||||||||
登録・組入れ開始(予定)日/Anticipated trial start date |
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フォロー終了(予定)日/Last follow-up date |
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入力終了(予定)日/Date of closure to data entry | ||||||||
データ固定(予定)日/Date trial data considered complete | ||||||||
解析終了(予定)日/Date analysis concluded |
その他/Other | ||
その他関連情報/Other related information | 英文参照 | Quality of each study will be assessed using The Newcastle-Ottawa Quality Assessment Scale for cohort studies.
Subgroup analyses focusing on history of previous anti-cancer drug treatment are planned. We will apply a random-model meta-analysis and generic inverse variance method to aggregate binomial AE frequencies (RevMan ver 5.4. Cochrane Collaboration, London, UK). Agresti and Coull method will be used for standard error estimation. P value less than 0.05 was the criteria of statistical significance. |
管理情報/Management information | ||||||||
登録日時/Registered date |
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最終更新日/Last modified on |
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閲覧ページへのリンク/Link to view the page | |
URL(日本語) | https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053339 |
URL(英語) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053339 |
研究計画書 | |
登録日時 | ファイル名 |
研究症例データ仕様書 | |
登録日時 | ファイル名 |
研究症例データ | |
登録日時 | ファイル名 |