Trial Radar IA | ||
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Lo studio clinico NCT07196345 per ESCC, TAS 102, Radioterapia 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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TAS-102 Plus Radiotherapy in Elderly ESCC Fase I, Fase II 45 Anziani
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07196345 è uno studio interventistico di Fase I Fase II volto a esaminare il trattamento per ESCC, TAS 102, Radioterapia, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 25 settembre 2025, con l'obiettivo di raggiungere 45 partecipanti. Sotto la guida di Qianfoshan Hospital, dovrebbe concludersi entro il 31 dicembre 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 29 settembre 2025.
Sommario breve
This study is a single-arm, multicenter clinical trial evaluating the efficacy and safety of radiotherapy combined with TAS-102 monotherapy in elderly patients with locally advanced esophageal cancer.
Treatment Phase: The treatment phase is divided into a Phase I stage and a Phase II stage. The Phase I stage aims to explore the maximum tolerated dose (MTD) of TAS-102 in elderly esophageal cancer patients. A total of...
Mostra di piùTitolo ufficiale
Efficacy and Safety of Trifluridine/Tipiracil Combined With Radiotherapy in Elderly Patients With Locally Advanced Esophageal Cancer
Patologie
ESCCTAS 102RadioterapiaAltri ID dello studio
- YXLL-KY-2025(055)
Numero NCT
Data di inizio (effettiva)
2025-09-25
Ultimo aggiornamento pubblicato
2025-09-29
Data di completamento (stimata)
2028-12-31
Arruolamento (previsto)
45
Tipo di studio
Interventistico
FASE
Fase I
Fase II
Fase II
Stato
Non ancora in arruolamento
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleTAS-102 + Radiotherapy | TAS-102 Administered orally at 35 mg/m²/dose twice daily (morning and evening), in a bi-weekly regimen on Days 1-5. Radioterapia Total dose of 50-60 Gy, delivered in 25-28 fractions, administered Monday through Friday (daily) until the full prescribed dose is achieved. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
2-years OS rate | The percentage of study participants who are still alive at 2 years after the starting date of the study drug, calculated from the starting date of the study drug to the date of death from any cause. | Approximately 24 months after the last subject participating in |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
ORR | The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first. | Approximately 4 months after the last subject participating in |
PFS | The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first (per RECIST 1.1). | Approximately 12 months after the last subject participating in |
Adverse Event (AE) | Type, incidence, grading (based on NCI-CTCAE v5.0 criteria), and duration of adverse event. | Up to approximately 2 years |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto anziano
Età minima
65 Years
Sessi idonei
Tutti
- Patients must have newly confirmed histologically or cytologically diagnosed esophageal squamous cell carcinoma.
- Age between 65 and 85 years.
- Esophageal cancer staged as IIB to IVB according to the 8th edition AJCC staging system (including IVB with supraclavicular or celiac lymph node metastasis, but excluding IVB with other distant metastases).
- ECOG performance status of 0 or 1.
- No history of esophageal perforation, active esophageal bleeding, or significant invasion of the trachea or major thoracic blood vessels.
- No prior anticancer therapy such as radiotherapy or chemotherapy. Adequate bone marrow function: hemoglobin ≥9 g/dL, white blood cells ≥3.0×10⁹/L, neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L.
- Adequate liver and kidney function: serum creatinine (Scr) ≤1.5×ULN, total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN.
- No history of interstitial lung disease.
- Forced expiratory volume (FEV1) ≥0.8 liters.
- Signed informed consent form before study initiation.
- Patients with hematogenous metastasis or distant lymph node metastasis (except supraclavicular or celiac lymph node metastasis), multiple esophageal cancer lesions, or malignant pleural/pericardial effusion.
- History of radiotherapy, chemotherapy, or surgery targeting the primary tumor or lymph nodes.
- Tracheoesophageal fistula, invasion of the trachea or main bronchi by the primary tumor, deep esophageal ulcer, or hematemesis.
- Severe comorbidities such as active infection, cardiovascular disease, or pulmonary disease.
- History of other malignancies except adequately treated non-melanoma skin cancer.
- Participation in another clinical trial within the past 30 days.
- Any other condition deemed by the investigator to preclude participation in the study.
Qianfoshan HospitalParte responsabile dello studio
Jiandong Zhang, Investigatore principale, Director of Department of Radiotherapy, Qianfoshan Hospital
Contatti principali dello studio
Contatto: Jiandong Zhang, Director of Department of Radiotherapy., +86 0531-89268118, [email protected]
1 Centri dello studio in 1 paesi
Shandong
The First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, 250000, China
Jiandong Zhang, Director of Department of Radiotherapy, Contatto, +86 0531-89268118, [email protected]