746
Participants
Start Date
December 24, 2018
Primary Completion Date
September 9, 2021
Study Completion Date
July 29, 2023
Sintilimab
For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
Cisplatin
75mg/m\^2 IV Q3W day 1
Paclitaxel
87.5 mg/m\^2 IV Q3W day 1, day 8 for first cycle and 175mg/m\^2 IV Q3W day 1 after first cycle
Fluorouracil
800 mg/m\^2 IV continuous infusion over 24 hours daily on Days 1-5 Q3W
Placebo
For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
Institut Jules Bordet, Brussels
Országos Onkológiai Intézet, Budapest
Cliniques Universitaires Saint-Luc Av., Brussels
Border Medical Oncology, East Albury
Universitair Ziekenhuis Leuven, Leuven
Austin Hospital, Heidelberg
Jósa András Oktatókórház, Nyíregyháza
Centre Hospitalier Regional de Verviers, Verviers
The Queen Elizabeth Hospital, Woodville South
St John of God Subiaco Hospital, Subiaco
Sir Charles Gairdner Hospital, Nedlands
University Hospital Gent, Ghent
CHU Hôpital de la Timone, Marseille
Centre François Baclesse, Caen
Complexo Hospitalario Universitario de Santiago, Santiago de Compostela
Faculte de Medecine, Dijon
Universite de Bourgogne - Faculte de Medecine - INSERM U866, Dijon
Hôpital Jean Minjoz, Bettancourt-la-Ferrée
Hospital Universitari Arnau de Vilanova de Lleida, Lleida
Hospital Universitario La Paz, Madrid
Hospital Universitario de Fuenlabrada, Fuenlabrada
Clínica Universidad de Navarra, Pamplona
IACT Health - John B. Amos Cancer center, Columbus
Institut Bergonié, Bordeaux
University Hospital Marqués de Valdecilla, Santander
Hospital Universitario Virgen Macarena, Seville
Consorci Hospital General Universitari de València, Valencia
Hospital Universitario Miguel Servet, Zaragoza
Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy
Oscar Lambret Centre, Lille
CHU Estaing, Clermont-Ferrand
CHU Estaing, Clermont-Ferrand
Stephenson Cancer Center, Oklahoma City
Hôpital Européen Georges Pompidou, Paris
Hôpital Charles-Nicolle de Rouen, Rouen
Texas Oncology, P.A., Austin
Rocky Mountain Cancer Centers, LLP, Denver
CHU de Poitiers, Poitiers
St. Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center, Anaheim
UC Irvine, Orange
Northwest Cancer Specialists, P.C., Vancouver
Hospital Universitario Fundacion Jimenez Diaz, Madrid
Beijing Cancer Hospital, Beijing
Hospital Universitari de Girona Doctor Josep Trueta, Girona
Hospital Universitario Ramón y Cajal, Madrid
Hospital del Mar, Barcelona
Hospital Universitario Vall d'Hebron, Barcelona
Parc Taulí Sabadell Hospital Universitari, Sabadell
Collaborators (1)
Fortrea
INDUSTRY
Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY