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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。

2026年9月20日 更新者:RemeGen Co., Ltd.

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

研究の種類

介入

入学 (推定)

555

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • BJ-Beijing
      • Beijing、BJ-Beijing、中国、100021
        • 募集
        • Beijing Cancer Hospital
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

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

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月12日

一次修了 (推定)

2029年6月30日

研究の完了 (推定)

2030年12月31日

試験登録日

最初に提出

2025年12月3日

QC基準を満たした最初の提出物

2025年12月23日

最初の投稿 (実際)

2026年1月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月22日

QC基準を満たした最後の更新が送信されました

2026年9月20日

最終確認日

2026年9月1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。

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