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治験 NCT07498907 (LUXUS41)（対象：上部尿路上皮癌）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma (LUXUS41) 第II相・フェーズ2 192 無作為化 非盲検 全生存期間
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07498907 (LUXUS41) は 治療 の研究で、上部尿路上皮癌 に関するものです。この 第II相・フェーズ2 介入研究 臨床試験 は現在 募集準備中 で、2026年5月1日 に開始予定です。192 名の参加者 の募集が計画されています。この試験は Peking University First Hospital によって主導され、2034年3月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月27日 です。
概要
This randomized, open-label, multicenter phase II study is designed to compare disitamab vedotin plus radiotherapy with gemcitabine plus carboplatin as adjuvant treatment in patients with HER2-expressing upper tract urothelial carcinoma after radical nephroureterectomy (RNU). Eligible patients must have postoperative pathologic stage pT3-pT4N0M0 or pTanyN+M0, HER2 expression defined as immunohistochemistry (IHC) 1+, ...もっと見る
公式タイトル
A Randomized, Prospective, Multicenter, Phase II Study of Disitamab Vedotin Plus Radiotherapy as Adjuvant Treatment for HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
疾患名
上部尿路上皮癌その他の研究識別子
- LUXUS41
- LUXUS4.1
NCT番号
開始日
2026-05-01
最終更新日
2026-03-27
終了予定日
2034-03-01
目標参加者数
192
試験の種類
介入研究
治験の相・段階
第II相・フェーズ2
状況
募集準備中
キーワード
UTUC
HER2
Disitamab Vedotin
Radiotherapy
Adjuvant Therapy
Cisplatin-Ineligible
Upper Tract Urothelial Carcinoma
HER2
Disitamab Vedotin
Radiotherapy
Adjuvant Therapy
Cisplatin-Ineligible
Upper Tract Urothelial Carcinoma
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Disitamab Vedotin Plus Radiotherapy Participants in this arm will receive disitamab vedotin plus radiotherapy as adjuvant treatment after radical surgery for HER2-expressing,cisplatin-ineligible upper tract urothelial carcinoma. | Disitamab Vedotin (RC48) Disitamab vedotin 2.0 mg/kg (maximum 120 mg) will be administered intravenously every 2 weeks for 12 cycles as adjuvant treatment after radical surgery. 放射線治療 Adjuvant radiotherapy will be delivered to the regional lymphatic drainage area at 45-50 Gy in 25 fractions over 5 weeks. Suspicious lymph nodes will receive 62.5 Gy in 25 fractions over 5 weeks. |
実薬対照薬Gemcitabine Plus Carboplatin Participants in this arm will receive gemcitabine plus carboplatin as adjuvant treatment after radical surgery for HER2-expressing cisplatin-ineligible upper tract urothelial carcinoma. | Gemcitabine (1000 mg/m2) Gemcitabine 1000 mg/m² will be administered on Days 1 and 8 of each 21-day cycle for 4 to 6 cycles as adjuvant treatment after radical surgery. カルボプラチン Carboplatin will be administered intravenously on Day 1 of each 21-day cycle at a target AUC of 4.5 to 5 for 4 to 6 cycles as adjuvant treatment after radical surgery. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
3-Year Disease-Free Survival | Disease-free survival (DFS) is defined as the time from randomization to first recurrence in the tumor bed, first metastasis, or death from any cause, whichever occurs first. | From randomization up to 3 years |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Overall Survival | Overall survival (OS) is defined as the time from randomization to death from any cause. | From randomization up to 3 years |
Metastasis-Free Survival | Metastasis-free survival (MFS) is defined as the time from randomization to first documented distant metastasis or death from any cause, whichever occurs first. | From randomization up to 3 years |
Local Recurrence-Free Survival | Local recurrence-free survival (LRFS) is defined as the time from randomization to first documented locoregional recurrence in the tumor bed or regional lymph nodes, or death from any cause, whichever occurs first. | From randomization up to 3 years |
Bladder Recurrence-Free Survival | Bladder recurrence-free survival (BRFS) is defined as the time from randomization to first documented bladder urothelial recurrence or death from any cause, whichever occurs first | From randomization up to 3 years |
Incidence of Adverse Events | Safety will be evaluated based on the incidence, type, severity, and attribution of adverse events during study treatment and follow-up. | From first dose through 30 days after completion of study treatment and up to 3 years for follow-up |
Patient-Reported Quality of Life | Patient-reported quality of life will be assessed using validated quality-of-life questionnaires during treatment and follow-up. | Baseline through 3 years |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Aged 18 years or older.
- Histologically confirmed upper tract urothelial carcinoma (UTUC) after radical nephroureterectomy (RNU).
- Postoperative pathologic stage pT3-pT4N0M0 or pTanyN+M0.
- HER2 expression confirmed by immunohistochemistry (IHC 1+, 2+, or 3+).
- Cisplatin-ineligible, defined as meeting at least one of the following criteria: ECOG performance status 2; creatinine clearance <60 mL/min; CTCAE grade 2 or higher hearing loss; CTCAE grade 2 or higher peripheral neuropathy; or New York Heart Association (NYHA) class III heart failure.
- Adequate organ function.
- Expected survival of at least 6 months.
- History of other active malignancies, except for adequately treated malignancies with low risk of recurrence.
- Prior systemic antitumor therapy before study treatment, or unresolved toxicities from prior therapy.
- Known hypersensitivity to disitamab vedotin, related agents, or any component of the study treatment.
- Severe active infection.
- Not adequately recovered from surgery.
- Pregnant or breastfeeding women.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
Peking University First HospitalRemeGen Co., Ltd.試験中央連絡先
連絡先: Xuesong Li, Dr., 010-83572418, [email protected]
連絡先: Zihao Tao, Dr., [email protected]
1 1カ国の場所
Peking University First Hospital, Beijing, China
Xuesong Li, Dr., 連絡先, 010-83572418, [email protected]
Qi Tang, Dr., 連絡先, [email protected]