This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with high-risk BCG-naive Papillary-Only non-muscle-invasive bladder cancer (NMIBC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
750
SHR-1501+BCG
Placebo +BCG
The First Medical Center of the Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGDisease-Free Survival (DFS) assessed by BICR: Disease-free survival is defined as the time from randomization to date of DFS event assessed by BICR.
Time frame: Up to approximately 5 years
Disease-Free Survival (DFS) assessed by investigator: Disease-free survival is defined as the time from randomization to date of DFS event assessed by investigator.
Time frame: Up to approximately 5 years
Overall Survival (OS): Overall Survival defined as the time from randomization to the date of death from any cause.
Time frame: Up to approximately 5 years.
Number of adverse events (AEs) as assessed by CTCAE v6.0.
Time frame: Up to approximately 5 years.
Number of serious adverse events (SAEs) as assessed by CTCAE v6.0.
Time frame: Up to approximately 5 years.
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