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Die klinische Studie NCT07498907 (LUXUS41) für Urothelkarzinom des oberen Trakts ist noch nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma (LUXUS41) Phase 2 192 Randomisiert Offene Studie Gesamtüberleben
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07498907 (LUXUS41) untersucht Behandlung im Zusammenhang mit Urothelkarzinom des oberen Trakts. Diese interventionsstudie der Phase 2 hat den Status noch nicht rekrutierend. Der Start ist für 1. Mai 2026 geplant, bis 192 Teilnehmer aufgenommen werden. Durchgeführt von Peking University First Hospital wird der Abschluss für 1. März 2034 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. März 2026 aktualisiert.
Kurzbeschreibung
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+, ...Mehr anzeigen
Offizieller Titel
A Randomized, Prospective, Multicenter, Phase II Study of Disitamab Vedotin Plus Radiotherapy as Adjuvant Treatment for HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
Erkrankungen
Urothelkarzinom des oberen TraktsWeitere Studien-IDs
- LUXUS41
- LUXUS4.1
NCT-Nummer
Studienbeginn (tatsächlich)
2026-05-01
Zuletzt aktualisiert
2026-03-27
Studienende (vorauss.)
2034-03-01
Geplante Rekrutierung
192
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Noch nicht rekrutierend
Stichwörter
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
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellDisitamab 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. Radiotherapie 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. |
Aktives VergleichspräparatGemcitabine 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. Carboplatin 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. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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.Zentrale Studienkontakte
Kontakt: Xuesong Li, Dr., 010-83572418, [email protected]
Kontakt: Zihao Tao, Dr., [email protected]
1 Studienstandorte in 1 Ländern
Peking University First Hospital, Beijing, China
Xuesong Li, Dr., Kontakt, 010-83572418, [email protected]
Qi Tang, Dr., Kontakt, [email protected]