HER2高発現進行性胃または胃食道接合部腺がんにおける、Disitamab Vedotinとトラスツズマブおよびチセレリズマブの併用療法と、化学療法とトラスツズマブの併用療法(ペンブロリズマブ併用または非併用)との比較研究。
HER2高発現進行胃/胃食道接合部腺癌に対する第一選択治療として、Disitamab Vedotin、トラスツズマブ、およびTislelizumabの併用療法と、化学療法(CAPOX)にトラスツズマブを併用し、ペムブロリズマブを併用するか否かの比較を評価する無作為化比較第III相試験
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma with HER2-high Expression.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前:Hongfang Li
- 電話番号:86+010-65018841
- メール:hongfang.li@remegen.com
研究場所
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-
BJ-Beijing
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Beijing、BJ-Beijing、中国、100021
- 募集
- Beijing Cancer Hospital
-
コンタクト:
- Lin shen
- 電話番号:86+010-88196561
- メール:doctorshenlin@sina.cn
-
-
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:
- Voluntarily consent to participate in the study and sign the informed consent form
- Expected survival period >12 weeks
- ECOG Performance Status 0 or 1
- Histologically confirmed unresectable locally advanced or metastatic --gastric/gastroesophageal junction adenocarcinoma
- No prior systemic therapy for locally advanced or metastatic gastric cancer; or disease progression or recurrence occurring ≥6 months after completion of neoadjuvant/adjuvant therapy
- HER2-high expression
- At least one assessable lesion according to RECIST v1.1 criteria
- Adequate organ function
- Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first treatment, and agree not to breastfeed or donate ova from the signing of the informed consent form until 6 months after the last treatment. Male subjects must agree not to donate sperm from the signing of the informed consent form until 6 months after the last treatment.
- Able to understand the study requirements and willing to comply with the study and follow-up procedures
Exclusion Criteria:
- Presence of central nervous system (CNS) metastasis and/or carcinomatous meningitis
- Peripheral neuropathy > Grade 1
- Tumor lesions with a tendency to bleed
- Severe gastrointestinal dysfunction that may affect drug intake, transport, or absorption
- Bone metastases with a risk of paraplegia
- Past or current interstitial lung disease, or severely impaired lung function
- Other malignancies within 5 years prior to randomization, except for those expected to be cured with treatment
- Pregnant or breastfeeding women
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: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:Disitamab Vedotin Combined with Trastuzumab and Tislelizumab
Participants will receive Disitamab Vedotin, Trastuzumab and Tislelizumab until the occurrence of intolerable toxicity, disease progression (investigator-assessed), initiation of new anti-tumor therapy, loss to follow-up, withdrawal of informed consent, or death (whichever occurs first). |
Disitamab Vedotin: 2.5 mg/kg, IV, D1, Q2W; Tislelizumab: 200 mg, IV, D1, Q3W Trastuzumab: Initial dose of 8mg/kg, followed by 6 mg/kg, IV, D1, Q3W; |
|
アクティブコンパレータ:Chemotherapy (CAPOX) Combined with Trastuzumab With or Without Pembrolizumab
Participants will receive CAPOX, Trastuzumab and Trastuzumab. Only subjects whose PD-L1 expression is confirmed as CPS ≥1 by the central laboratory will receive pembrolizumab. Treatment will continue until the occurrence of intolerable toxicity, disease progression (investigator-assessed), initiation of new anti-tumor therapy, loss to follow-up, withdrawal of informed consent, or death (whichever occurs first). |
Trastuzumab: Initial dose of 8mg/kg, followed by 6 mg/kg, IV, D1, Q3W; Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W; Pembrolizumab: 200mg, IV, D1, Q3W |
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 |
|---|---|---|
|
Progression-Free Survival (assessed by the BIRC)
時間枠:24 months
|
Progression-free survival (PFS) is defined as the time from the date of randomization to disease progression per RECIST 1.1 as assessed by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first. |
24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival
時間枠:up to 5 years
|
Overall survival (OS) refers to the time from the date of randomization to the date of death from any cause. |
up to 5 years
|
|
Progression-Free Survival (assessed by the investigator)
時間枠:24 months
|
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by investigators or death due to any cause, whichever occurs first. |
24 months
|
|
Objective Response Rate (assessed by the BIRC and investigators)
時間枠:24 months
|
ORR is defined as the percentage of subjects who have a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 as assessed by BICR and investigators . |
24 months
|
|
Disease Control Rate (assessed by the BIRC and investigators)
時間枠:24 months
|
DCR is defined as the proportion of subjects whose BOR is rated as CR, PR, or stable disease (SD) per RECIST 1.1 as assessed by BICR/ investigators . |
24 months
|
|
Duration of Response (assessed by the BIRC and investigators)
時間枠:24 months
|
For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. |
24 months
|
|
Patient-Reported Outcomes (EORTC-QLQ-C30)
時間枠:24 months
|
The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the global health status/QoL, which are scored 1 ("very poor") to 7 ("excellent"). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. |
24 months
|
|
Patient-Reported Outcomes (EORTCQLQ-STO22)
時間枠:24 months
|
Quality of life in patients with colorectal cancer is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) STO22. It will be evaluated at Screening and Tumor Assessment Visit. The higher score means the worse quality of life. |
24 months
|
|
Patient-Reported Outcomes (EQ-5D-5L)
時間枠:24 months
|
EQ-5D-5L is a standardized instrument for use as a measure of health outcomes consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status.It was developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples. |
24 months
|
|
Adverse Events
時間枠:24 months
|
Incidence, severity, and relationship to the investigational product of adverse events (AEs) and serious adverse events (SAEs) |
24 months
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
追加の関連 MeSH 用語
- 部位別新生物
- 新生物
- 消化器腫瘍
- 消化器系腫瘍
- 消化器系疾患
- 消化器疾患
- 胃の病気
- 胃の新生物
- アミノ酸、ペプチド、およびタンパク質
- タンパク質
- 有機化学物質
- 複素環化化合物、1リング
- 複素環化化合物
- 核酸、ヌクレオチド、およびヌクレオシド
- 抗体、モノクローナル、ヒト化
- 抗体、モノクローナル
- 抗体
- 免疫グロブリン
- 免疫タンパク質
- 血液タンパク質
- 血清グロブリン
- グロブリン
- 調整錯体
- デオキシシチジン
- シチジン
- ピリミジンヌクレオシド
- ピリミジン
- ヌクレオシド
- ウラシル
- ピリミジノン
- デオキシリボヌクレオシド
- フルオロウラシル
- トラスツズマブ
- カペシタビン
- オキサリプラチン
- イジタマブヴェドチン
- ペンブロリズマブ
- ティスレリズマブ
その他の研究ID番号
- RC48-C040
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
米国FDA規制機器製品の研究
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