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Активно (без набиране) Фаза 3 NCT03383458

A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Фаза 3 – широко изпитване преди одобрение
Заболявания: Hepatocellular Carcinoma Liver Cancer

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence
Кой може да участва
Inclusion Criteria: * Participants with a first diagnosis of HCC who have undergone a curative resection or ablation * Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC * Child-Pugh Score 5 or 6 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * Any evidence of tumor metastasis or co-existing malignant disease * Participants previously receiving any prior therapy for HCC, including loco-regional therapies * Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation * Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella \[MMR\]). Other protocol defined inclusion/exclusion criteria apply
Места на провеждане 24
Argentina (1)
Local Institution - 0243
Gorriti , Buenos Aires
Австралия (1)
Local Institution - 0239
Blacktown , New South Wales
Белгия (1)
Local Institution - 0033
Brussels
Бразилия (1)
Local Institution - 0090
Belo Horizonte , Minas Gerais
Канада (1)
Local Institution
Calgary , Alberta
Chile (1)
Local Institution - 0248
Santiago , Santiago Metropolitan
Colombia (1)
Local Institution - 0256
Bogotá
Франция (1)
Local Institution - 0057
Bobigny
Германия (1)
Local Institution - 0024
Aachen
Hong Kong (1)
Local Institution - 0120
Hong Kong
Италия (1)
Local Institution - 0136
Messina , ME
Япония (1)
Local Institution - 0183
Kashiwa-shi , Chiba
Mexico (1)
Local Institution - 0148
Cuauhtémoc , Durango
Нидерландия (1)
Local Institution - 0263
Maastricht
New Zealand (1)
Local Institution - 0240
Auckland
Puerto Rico (1)
Local Institution - 0231
San Juan
Румъния (1)
Local Institution
Brasov
Russia (1)
Local Institution - 0032
Saint Petersburg , Sankt-Peterburg
Сингапур (1)
Local Institution - 0042
Singapore
Южна Корея (1)
Local Institution - 0191
Suwon , Gyeonggi-do
Испания (1)
Local Institution - 0069
Barcelona
Taiwan (1)
Local Institution - 0131
Tainan , TNN
Великобритания (1)
Local Institution - 0111
London
САЩ (1)
Local Institution - 0081
Anniston , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
18.04.2018
Крайна дата
27.02.2031
Регистрационен номер
NCT03383458
Източник
anzctr
Запитване за медицински туризъм

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