The study was designed to evaluate the efficacy and safety of HRS-4642 monotherapy or in combination with adebrelimab in the treatment of advanced biliary tract tumor patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
HRS-4642 will be administrated per dose level in which the patients are assigned.
HRS-4642 and adebrelimab will be administrated per dose level in which the patients are assigned.
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGObjective response rate (ORR) by RECIST V1.1
The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.
Time frame: up 2 years
Adverse events(AEs), serious adverse events(SAEs)
AEs and SAEs occurred from the first dose of treatment to 30 days after the last dose of HRS-4642 or 90 days after the last dose of adebrelimab (whichever comes late).
Time frame: up 2 years
Disease control rate (DCR)
The DCR is defined as complete remission (CR) rate + partial remission (PR) rate + stable disease (SD).
Time frame: up 2 years
Progression-free survival (PFS)
PFS is defined as Time from the date of enrollment to of disease
Time frame: up 2 years
Overall survival (OS)
OS is defined as time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Time frame: up 2 years
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