UMIN-CTR 臨床試験登録情報の閲覧

基本情報/Basic information
一般向け試験名/Public title	トラスツズマブを含む初回化学療法に不応のHER2過剰発現を有する治癒切除不能進行・再発胃癌に対するトラスツズマブ/イリノテカン併用療法の第II相試験	Phase II study of trastuzumab with irinotecan in HER2-positive metastatic or advanced gastric cancer patients previously treated with trastuzumab and failed
一般向け試験名略称/Acronym	HGCSG 1201	HGCSG 1201
科学的試験名/Scientific Title	トラスツズマブを含む初回化学療法に不応のHER2過剰発現を有する治癒切除不能進行・再発胃癌に対するトラスツズマブ/イリノテカン併用療法の第II相試験	Phase II study of trastuzumab with irinotecan in HER2-positive metastatic or advanced gastric cancer patients previously treated with trastuzumab and failed
科学的試験名略称/Scientific Title:Acronym	HGCSG 1201	HGCSG 1201
試験実施地域/Region	日本/Japan

対象疾患/Condition
対象疾患名/Condition	HER2過剰発現を有する治癒切除不能進行・再発胃癌	HER2-positive metastatic or advanced gastric cancer
疾患区分1/Classification by specialty	消化器内科学（消化管）/Gastroenterology 血液・腫瘍内科学/Hematology and clinical oncology 消化器外科(消化管）/Gastrointestinal surgery
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	トラスツズマブを含む初回化学療法に不応のHER2過剰発現を有する切除不能進行・再発胃癌に対するトラスツズマブ/イリノテカン併用療法の有効性と安全性を評価する。	To assess the efficacy and/or safety of trastuzumab with irinotecan in HER2-positive metastatic or advanced gastric cancer patients previously treated with trastuzumab and failed
目的2/Basic objectives2	安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others
試験の性質1/Trial characteristics_1	探索的/Exploratory
試験の性質2/Trial characteristics_2	説明的/Explanatory
試験のフェーズ/Developmental phase	第Ⅱ相/Phase II

評価/Assessment
主要アウトカム評価項目/Primary outcomes	奏効率	response rate
副次アウトカム評価項目/Key secondary outcomes	無増悪生存期間、6ヶ月生存率、安全性、HER2 status別（IHC 3+群、IHC 2+/FISH+群）のサブグループ解析、HER2再検査別（非再検査群、再検査群）のサブグループ解析、HER2再検査群におけるHER2再検査status別（陰転化群、非陰転化群）のサブグループ解析	progression-free survival, six-month survival rate, safety, sub-group analysis by HER2 status(IHC3+, IHC2+/FISH+), sub-group analysis by retesting of HER2 status(retest, no retest), sub-group analysis by HER2 status in HER2 resteted population(changed from most positive and/or positive to positve and/or negative, not changed)

基本事項/Base
試験の種類/Study type	介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design	単群/Single arm
ランダム化/Randomization	非ランダム化/Non-randomized
ランダム化の単位/Randomization unit
ブラインド化/Blinding	オープン/Open -no one is blinded
コントロール/Control	無対照/Uncontrolled
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	1
介入の目的/Purpose of intervention	治療・ケア/Treatment
介入の種類/Type of intervention	医薬品/Medicine
介入1/Interventions/Control_1	登録後2週以内に、トラスツズマブ/イリノテカン併用療法を開始し、原則、増悪まで繰り返す 1. トラスツズマブは初回8mg/kg、2回目以降6mg/kgを90分以上かけて点滴静注し、3週毎に繰り返す 2. イリノテカンは150mg/m2を90分かけて点滴静注し、2週毎に繰り返す	trastuzumab wiht irinotecan started within 2 weeks of enrollment and repeated until disease progression, unacceptable toxicity, or withdrawal of consent 1. trastzumab given by intravenous infusion in 90 or more minutes at a dose of 8mg/kg on day 1 of the first cycle, followed by 6mg/kg every 3 weeks 2. irinotecan given by intravenous infusion in 90 minutes at a dose of 150mg/m2 every 2 weeks
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	20 歳/years-old 以上/<=
年齢（上限）/Age-upper limit	適用なし/Not applicable
性別/Gender	男女両方/Male and Female
選択基準/Key inclusion criteria	1. 組織学的に胃原発の腺癌と確認された、StageIV（胃がん取扱い規約第14版）または切除不能な再発の患者 2. HER2過剰発現（HER2：IHC 3+またはIHC 2+かつFISH+）が確認されている患者 3. 前治療としてトラスツズマブを含む初回化学療法に不応な患者 4. Response Evaluation Criteria in Solid Tumor(RECIST) ver1.1に従い、登録前28日以内の画像検査（CTスキャン又はMRI）で初回治療の増悪・再発と、測定可能病変の存在が確認されている患者 5. 登録時に初回化学療法の最終投与から14日以上経過している患者 6. イリノテカンの治療歴がない患者 7. 年齢20歳以上の患者 8. Performance status(ECOG scale)：0～2の患者 9. 登録前14日以内の主要臓器機能について、基準を満たしている患者 10. 心機能が標準値内である患者：心エコーまたはMUGAスキャン法で登録前3ヶ月以内に測定したLVEFが50%以上 11. 本人より文書による同意が得られている患者	1. histologically, confirmed inoperable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach 2. HER2 status scored as 3+ on immunohistochemistry or fluorescence in-situ hybridization positive 3. prior trastuzumab and resistant radiologically confirmed disease progression within 28 days after last dose of 1st line therapy including trastuzumab 4. CT or MRI imaging of disease progression of 1st line therapy by RECIST criteria ver. 1.1 within 28 days of enrollment, and mesurable lesions 5. 14 days or more after last dose of 1st line therapy 6. no prior irinotecan 7. aged 20 or older 8. ECOG performance status 0-2 9. adequate organ function within 14 days of enrollment 10. adequate cardiac function: LVEF 50% or more by echocardiography or MUGA scan within 3 months of enrollment 11. written first-person informed consent
除外基準/Key exclusion criteria	1. 活動性の重複癌(治癒した皮膚基底細胞がん、子宮頚部上皮がん、もしくは内視鏡的粘膜切除により治癒切除された消化器癌は除く)を有する患者 2. 重篤、またはコントロール不良な合併症(感染症、肺線維症、腸管麻痺、腸閉塞、コントロール不良の糖尿病、肝硬変、コントロール不良の高血圧症、1年以内の心筋梗塞の既往もしくは不安定狭心症等)を有する患者 3. 活動性(顕著あるいはコントロール不能)の消化管出血が認められる 4. 心嚢水を有する患者、ドレナージなど治療を必要とする胸水・腹水を有する患者 5. 妊娠中・妊娠の可能性、または授乳中の患者、および挙子を希望する患者 6. その他、担当医師により当該臨床試験の参加が不適切であると判断される患者	1. past or current history(within the last 5 years) of malignancies except for the indication under this study and curatively treated: -Basal and squamous cell carcinoma of the skin -In-situ carcinoma of the cervix 2. serious and/or uncontrolled complications(infection, pulmonary fibrosis, bowel paralysis, bowel obstrucion, uncontrolled diabetes, hepatic cirrhosis, uncontrolled hypertension, current history(within a year) of myocardial infarction and/or unstable angina) 3. active(obvious or uncontrolled) gastrointestinal hemorrhage 4. cardiac effusion, pleural and/or peritoneal effusion requiring treatment of drainage 5. pregnancy and lactation, and/or without intention of virth control 6. any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
目標参加者数/Target sample size	60

責任研究者/Research contact person
責任研究者/Name of lead principal investigator	名 嘉人 ミドルネーム 姓 小松	名 Yoshito ミドルネーム 姓 Komatsu
所属組織/Organization	北海道大学病院	Hokkaido University Hospital
所属部署/Division name	腫瘍センター	Department of Cancer Chemotherapy
郵便番号/Zip code	060-8648
住所/Address	北海道札幌市北区北14条西5丁目	North 14, West 5, Kita-Ku, Sapporo, Hokkaido, Japan
電話/TEL	011-716-1161
Email/Email	ykomatsu@ac.cyberhome.ne.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	名 菜々子 ミドルネーム 姓 小野	名 Nanako ミドルネーム 姓 Ono
組織名/Organization	北海道大学病院	Hokkaido University Hospital
部署名/Division name	高度先進医療支援センター	Department of Clinical Trial Management
郵便番号/Zip code	060-8648
住所/Address	北海道札幌市北区北14条西5丁目	North 14, West 5, Kita-ku, Sapporo, Hokkaido, Japan
電話/TEL	011-706-7413
試験のホームページURL/Homepage URL
Email/Email	nanako-ono@huhp.hokudai.ac.jp

実施責任組織/Sponsor
機関名/Institute	その他	NPO Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
機関名/Institute （機関選択不可の場合）	特定非営利活動法人　北海道消化器癌化学療法研究会（HGCSG）
部署名/Department

研究費提供組織/Funding Source
機関名/Organization	その他	NPO Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
機関名/Organization （機関選択不可の場合）	特定非営利活動法人　北海道消化器癌化学療法研究会（HGCSG）
組織名/Division
組織の区分/Category of Funding Organization	財団/Non profit foundation
研究費拠出国/Nationality of Funding Organization	日本	Japan

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	北海道大学病院　自主臨床研究審査委員会	Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
住所/Address	北海道札幌市北区北14条西5丁目	Kita 14, Nishi 5, Kita-Ku, Sapporo, Hokkaido
電話/Tel	011-706-7636
Email/Email	crjimu@huhp.hokudai.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	北海道大学病院、他、HGCSG参加施設ならびに研究協力施設（約30施設）

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	2012 年 04 月 01 日

関連情報/Related information
プロトコル掲載URL/URL releasing protocol	No
試験結果の公開状況/Publication of results	最終結果が公表されている/Published

結果/Result
結果掲載URL/URL related to results and publications	https://doi.org/10.1093/oncolo/oyab062
組み入れ参加者数/Number of participants that the trial has enrolled	16
主な結果/Results	Sixteen patients were enrolled in a 3-year pre-planned registration period. This study was prematurely closed due to poor patient accrual. The ORR and disease control rate were 6.7% (95% CI, 0.2-32.0) and 53.3% (95% CI, 26.6-78.7). The median PFS and overall survival (OS) were 2.4 months (95% CI, 0.0-5.2) and 9.7 months (95% CI, 8.2-11.2), respectively. The most frequently reported grades 3-4 adverse events were neutropenia (40%), anemia (27%), anorexia (33%), and fatigue (33%).	Sixteen patients were enrolled in a 3-year pre-planned registration period. This study was prematurely closed due to poor patient accrual. The ORR and disease control rate were 6.7% (95% CI, 0.2-32.0) and 53.3% (95% CI, 26.6-78.7). The median PFS and overall survival (OS) were 2.4 months (95% CI, 0.0-5.2) and 9.7 months (95% CI, 8.2-11.2), respectively. The most frequently reported grades 3-4 adverse events were neutropenia (40%), anemia (27%), anorexia (33%), and fatigue (33%).
主な結果入力日/Results date posted	2022 年 09 月 18 日
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	2022 年 03 月 18 日
参加者背景/Baseline Characteristics	Number of patients, male 9 Number of patients, female 6 Age Median (range): 65 (42-78) years Number of prior systemic therapies Median: 1 Performance status: Eastern Cooperative Oncology Group (ECOG) 0-8 1-7 2-0 3-0 Unknown-0 Other Histology: adenocarcinoma, 15 Extent of disease: metastatic, 13; recurrent, 2 The number of metastatic sites per patient: median 2 (range 1-3) Metastatic site: lymph node, 11; liver, 10; lung, 3; peritoneum, 2 Previous gastrectomy: 3 Previous adjuvant therapy 2 HER2 status: IHC 2+/FISH positive, 5; IHC 3+, 10 Prior therapy: trastuzumab with capecitabine plus cisplatin, 12; trastuzumab with S-1 plus cisplatin, 3 Cancer types or histologic subtypes Intestinal, 9; diffuse, 6	Number of patients, male 9 Number of patients, female 6 Age Median (range): 65 (42-78) years Number of prior systemic therapies Median: 1 Performance status: Eastern Cooperative Oncology Group (ECOG) 0-8 1-7 2-0 3-0 Unknown-0 Other Histology: adenocarcinoma, 15 Extent of disease: metastatic, 13; recurrent, 2 The number of metastatic sites per patient: median 2 (range 1-3) Metastatic site: lymph node, 11; liver, 10; lung, 3; peritoneum, 2 Previous gastrectomy: 3 Previous adjuvant therapy 2 HER2 status: IHC 2+/FISH positive, 5; IHC 3+, 10 Prior therapy: trastuzumab with capecitabine plus cisplatin, 12; trastuzumab with S-1 plus cisplatin, 3 Cancer types or histologic subtypes Intestinal, 9; diffuse, 6
参加者の流れ/Participant flow	Number of patients screened 16 Number of patients enrolled 16 Number of patients evaluable for toxicity 15 Number of patients evaluated for efficacy 15	Number of patients screened 16 Number of patients enrolled 16 Number of patients evaluable for toxicity 15 Number of patients evaluated for efficacy 15
有害事象/Adverse events	The most frequently reported grades 3-4 AEs were neutropenia (40%), anemia (27%), anorexia (33%), and fatigue (33%). The median left ventricular ejection fractions before and after treatment were 66% and 62%, respectively. Regarding the causes of treatment discontinuation, 12 patients had disease progression, and 3 patients withdrew consent in response to AEs. Specifically, 2 patients withdrew because of grade 3 anorexia and fatigue, and 1 patient withdrew because of grade 2 anorexia and grade 1 alopecia.	The most frequently reported grades 3-4 AEs were neutropenia (40%), anemia (27%), anorexia (33%), and fatigue (33%). The median left ventricular ejection fractions before and after treatment were 66% and 62%, respectively. Regarding the causes of treatment discontinuation, 12 patients had disease progression, and 3 patients withdrew consent in response to AEs. Specifically, 2 patients withdrew because of grade 3 anorexia and fatigue, and 1 patient withdrew because of grade 2 anorexia and grade 1 alopecia.
評価項目/Outcome measures	(Median) duration assessments PFS 2.4 months, CI: 0.0-5.2 (Median) duration assessments OS 9.7 months, CI: 8.2-11.2 (Median) duration assessments duration of treatment 1.9 months	(Median) duration assessments PFS 2.4 months, CI: 0.0-5.2 (Median) duration assessments OS 9.7 months, CI: 8.2-11.2 (Median) duration assessments duration of treatment 1.9 months
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	試験終了/Completed
プロトコル確定日/Date of protocol fixation	2012 年 03 月 01 日
倫理委員会による承認日/Date of IRB	2012 年 03 月 12 日
登録・組入れ開始（予定）日/Anticipated trial start date	2012 年 04 月 01 日
フォロー終了(予定)日/Last follow-up date	2016 年 03 月 01 日
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

管理情報/Management information
登録日時/Registered date	2012 年 04 月 01 日
最終更新日/Last modified on	2022 年 09 月 18 日

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/icdr/ctr_view.cgi?recptno=R000009008
URL(英語)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009008