Trial Radar IA | ||
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Lo studio clinico NCT07498907 (LUXUS41) per Carcinoma uroteliale del tratto superiore è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Vista a schede
Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma (LUXUS41) Fase II 192 Randomizzato In aperto Sopravvivenza globale
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La sperimentazione clinica NCT07498907 (LUXUS41) è uno studio interventistico di Fase II volto a esaminare il trattamento per Carcinoma uroteliale del tratto superiore, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 maggio 2026, con l'obiettivo di raggiungere 192 partecipanti. Sotto la guida di Peking University First Hospital, dovrebbe concludersi entro il 1 marzo 2034. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
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+, ...Mostra di più
Titolo ufficiale
A Randomized, Prospective, Multicenter, Phase II Study of Disitamab Vedotin Plus Radiotherapy as Adjuvant Treatment for HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
Patologie
Carcinoma uroteliale del tratto superioreAltri ID dello studio
- LUXUS41
- LUXUS4.1
Numero NCT
Data di inizio (effettiva)
2026-05-01
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2034-03-01
Arruolamento (previsto)
192
Tipo di studio
Interventistico
FASE
Fase II
Stato
Non ancora in arruolamento
Parole chiave
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
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleDisitamab 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. Radioterapia 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. |
Comparatore attivoGemcitabine 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. Carboplatino 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. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- 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.Contatti principali dello studio
Contatto: Xuesong Li, Dr., 010-83572418, [email protected]
Contatto: Zihao Tao, Dr., [email protected]
1 Centri dello studio in 1 paesi
Peking University First Hospital, Beijing, China
Xuesong Li, Dr., Contatto, 010-83572418, [email protected]
Qi Tang, Dr., Contatto, [email protected]