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HIMALAYA: A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma - D419CC00002

Studio Clinico

Patologia: Epatocarcinoma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

- HCC based on histopathological confirmation
- No prior systemic therapy for HCC
- Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C
- Child-Pugh Score class A
- ECOG performance status of 0 or 1 at enrollment

Criteri di esclusione: 

- Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
- Clinically meaningful ascites
- Main portal vein tumor thrombosis
- Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
- HBV and HVC co-infection, or HBV and Hep D co-infection

Trattamento sperimentale: 

Arm 1: Durvalumab

Arm 2: Durvalumab in combination with tremelimumab (Regimen 1)

Arm 3: Durvalumab in combination with tremelimumab (Regimen 2)

Trattamento di controllo: 

Arm 4: Sorafenib

Obiettivi primari dello studio: 

Overall Survival (OS) [Time Frame: From the date of randomization until death due to any cause, assessed up to 4 years]

Obiettivi secondari dello studio: 

- Time to Progression (TTP) [Time Frame: From randomization until objective tumor progression, assessed up to 4 years]
- Progression-free survival (PFS) [Time Frame: From date of randomization until the date of objective disease progression or death, assessed up to 4 years. ]
- Objective response rate (ORR) [Time Frame: Until progression, assessed up to 4 years]
- Disease control rate (DCR) [Time Frame: Until progression, assessed up to 4 years]
- Duration of response (DoR) [Time Frame: From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression, assessed up to 4 years]
- Health status/quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30) [Time Frame: From randomization up to approximately 3 months from the treatment discontinuation, assessed up to 4 years]
- Presence of ADA for durvalumab and tremelimumab [ Time Frame: Starting prior to the first dose of the treatment up to approximately 3 months from the treatment discontinuation, assessed up to 4 years]
- The pharmacokinetics (PK) of durvalumab and tremelimumab as determined by trough concentration [Time Frame: Starting prior to the first dose of the treatment up to approximately 3 months from the treatment discontinuation, assessed up to 4 years]
- Disease-related symptoms measured by EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) [Time Frame: From randomization up to approximately 3 months from the treatment discontinuation, assessed up to 4 years]
- The pharmacokinetics (PK) of durvalumab and tremelimumab as determined by peak concentration [Time Frame: Starting prior to the first dose of the treatment up to approximately 3 months from the treatment discontinuation, assessed up to 4 years]

Centri partecipanti

Nord Italia

IRCCS - IRST
Via P. Maroncelli 40 - 47014 Meldola - FC

Riferimento: Dr. Giovanni Luca Paolo Frassineti
Telefono: 0543739271
Email: luca.frassineti@irst.emr.it

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI

Riferimento: Dr. Luca Gianni
Telefono: 0226436529

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

Riferimento: Dr.ssa Lorenza Rimassa
Telefono: 0282246280
Email: lorenza.rimassa@humanitas.it

 

Centro Italia

Azienda Ospedaliera di Perugia
Via Dottori 1 - 06132 Perugia - PG

Riferimento: Dr. Fausto Roila
Telefono: 0755784211
Email: fausto.roila@ospedale.perugia.it

 

AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI

Riferimento: Dr. Gianluca Masi
Email: g.masi@ao-pisa.toscana.it

 

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM

Riferimento: Prof. Antonio Gasbarrini
Telefono: 0630154217
Email: agasbarrini@rm.unicatt.it

 

Sud Italia e isole

A.O. 'G. Rummo'
Via dell'Angelo 1 - 82100 Benevento - BN

Riferimento: Dr. Domenico Germano
Telefono: 082457724
Email: domgerm@libero.it

 

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT03298451

Data di inserimento: 06.03.2019

Promotore

AstraZeneca

CRO

/

Principal Investigator ITALIA

Istituto Clinico Humanitas, Rozzano (Milano)

Riferimento: Dr.ssa Lorenza Rimassa

Telefono: 0282246280

Email: lorenza.rimassa@humanitas.it

Localita: Rozzano (MI)

 

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