This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
543
Overall Survival (OS)
OS was defined as the time from randomization to death from any cause.
Time frame: Up to approximately 3 years
Progression-free Survival (PFS) Evaluated by the Blinded Independent Review Committee (BIRC) Based on RECIST v1.1
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) by tumor image evaluation or death from any cause whichever occurs first as determined by BIRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions and the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Up to approximately 3 years
Objective Response Rate (ORR)
ORR defined as the percentage of subjects with complete response (CR) or partial response (PR) evaluated by the BIRC or investigator based on RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Overall Response (OR)=CR+PR.
Time frame: Up to approximately 3 years
Disease Control Rate (DCR)
DCR defined as the percentage of subjects with complete response, partial response or stable disease (SD) ≥ 8 weeks evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: Up to approximately 3 years
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Beverly Hills Cancer Center
Beverly Hills, California, United States
University of California San Diego (UCSD)-Moores Cancer Center
La Jolla, California, United States
University of California - Irvine
Orange, California, United States
University of Maryland
Baltimore, Maryland, United States
Cornell University Weill Cornell Medical College
New York, New York, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Renovatio Clinical
The Woodlands, Texas, United States
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
...and 111 more locations
Duration of Response (DOR)
DOR defined as time from the date of first record of objective response (CR or PR) to the first occurrence of radiological progression or death, whichever comes first, evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.
Time frame: Up to approximately 3 years