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Protocol Addendum I4T-MC-JVDE open label cohort addendum

Studio Clinico

Patologia: Epatocarcinoma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: III

Richiesta mandatoria di tessuto: No

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- Patients with cytological or histological diagnosis of HCC
- Patients who received 1 prior systemic therapy regimen, excluding prior sorafenib for the treatment of HCC
- Patients who discontinued from prior systemic therapy >=14 days prior to enrollment.
- Patients who have radiographically confirmed disease progression during or after discontinuation of prior systemic therapy or discontinued prior systemic treatment because of intolerance, despite appropriate management and supportive care.
- Patient with 1 measurable lesion per Response Evaluation Criteria In Solid Tumor (RECIST).
- Patients who are 18 years of age or older
- Patients with a Child-Pugh score of <7
- Patients have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC stage B disease not amenable to locoregional therapy or refractory to the therapy.
- Patients with a baseline AFP >=400 ng/mL
- Performance status of 0,1 ECOG
- Adequate organ function

Criteri di esclusione: 

- The patient has or had fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
- The patient received any hepatic locoregional therapy (including radiation, surgery, hepatic arterial embolization, chemoembolization, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) following prior systemic therapy or within 28 days prior to randomization.
- The patient had a previous or has concurrent malignancy
- The patient has previously documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
- The patient has a history of or current hepatic encephalopathy (any grade) or clinically meaningful ascites
- Ongoing hepatorenal syndrome
- Prior liver transplant

Numero di pazienti previsti: 

44

Trattamento sperimentale: 

Ramucirumab (Cyramza®)

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

To evaluate the safety profile of ramucirumab in patients with advanced HCC after prior systemic therapy other than sorafenib.

Obiettivi secondari dello studio: 

To evaluate the Overall Survival, Progression Free Survival, time to progression, response rate, PK, patient reported outcome.

Data di inizio dell'arruolamento: 01.10.2018

Data di fine dell'arruolamento: 31.10.2019

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
Dipartimento di Oncologia Medica

Riferimento: Prof. Giovanni Brandi
Email: giovanni.brandi@unibo.it

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
Oncologia medica I

Riferimento: Dr.ssa Vittorina Zagonel
Telefono: 0498215661
Email: vittorina.zagonel@iov.veneto.it

 

Sud Italia e isole

A.O. 'G. Rummo'
Via dell'Angelo 1 - 82100 Benevento - BN
Dipartimento di Oncologia Medica

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

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2014-005068-13

Data di inserimento: 31.01.2019

Promotore

Eli Lilly and Company

Riferimento: Dr.ssa Morena Caira

CRO

IQVIA

Principal Investigator ITALIA

Azienda Ospedaliera G. Rummo - Divisione di Oncologia - Benevento

Riferimento: Dr. Domenico Germano

Telefono: 082457724

Email: domgerm@libero.it

Localita: Benevento

 

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