Disitamab Vedotin plus Strahlentherapie zur adjuvanten Behandlung von HER2-exprimierendem, Cisplatin-ungeeignetem oberen Harntrakt-Urothelkarzinom (LUXUS41)
A Randomized, Prospective, Multicenter, Phase III Study of Disitamab Vedotin Plus Radiotherapy as Adjuvant Treatment for HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
This randomized, open-label, multicenter phase III 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+, 2+, or 3+, and be cisplatin-ineligible. Patients will be randomized in a 2:1 ratio to receive disitamab vedotin plus radiotherapy or gemcitabine plus carboplatin. The primary endpoint is 3-year disease-free survival. Secondary endpoints include overall survival, metastasis-free survival, local recurrence-free survival, bladder recurrence-free survival, incidence of adverse events, and patient-reported quality of life.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 3
Kontakte und Standorte
Studienkontakt
- Name: Xuesong Li, Dr.
- Telefonnummer: 010-83572418
- E-Mail: pineneedle@sina.com
Studieren Sie die Kontaktsicherung
- Name: Zihao Tao, Dr.
- E-Mail: taozihao@pku.edu.cn
Studienorte
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Beijing, China
- Rekrutierung
- Peking University First Hospital
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Kontakt:
- Xuesong Li, Dr.
- Telefonnummer: 010-83572418
- E-Mail: pineneedle@sina.com
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Kontakt:
- Qi Tang, Dr.
- E-Mail: drtangq@bjmu.edu.cn
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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 2.0 mg/kg (maximum 120 mg) will be administered intravenously every 2 weeks for 12 cycles as adjuvant treatment after radical surgery. 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. |
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Aktiver Komparator: 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 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 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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3-Year Disease-Free Survival
Zeitfenster: From randomization up to 3 years
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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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Overall Survival
Zeitfenster: From randomization up to 3 years
|
Overall survival (OS) is defined as the time from randomization to death from any cause. |
From randomization up to 3 years
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Metastasis-Free Survival
Zeitfenster: From randomization up to 3 years
|
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
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Local Recurrence-Free Survival
Zeitfenster: From randomization up to 3 years
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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
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Bladder Recurrence-Free Survival
Zeitfenster: From randomization up to 3 years
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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
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Incidence of Adverse Events
Zeitfenster: From first dose through 30 days after completion of study treatment and up to 3 years for follow-up
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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
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Patient-Reported Quality of Life
Zeitfenster: Baseline through 3 years
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Patient-reported quality of life will be assessed using validated quality-of-life questionnaires during treatment and follow-up. |
Baseline through 3 years
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- LUXUS4.1
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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