This is an open-label, single-arm, Phase II investigator-initiated trial of antibody-drug conjugate combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 for treatment of advanced refractory solid tumors with HER-2 positive
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
RC48-ADC combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2
The First Bethune Hospital of Jilin University
Changchun, China
The First People's Hospital of Changzhou
Changzhou, China
Objective Response Rate (ORR)
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
Time frame: 24 months
Progression-free Survival (PFS)
PFS was defined as the time from the first administration of study treatment to the first occurrence of disease progression as determined by investigator using RECIST v1.1 or death from any cause, whichever comes first.
Time frame: 24 months
Disease control rate (DCR)
DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD)
Time frame: 24 months
Overall survival (OS)
OS was defined as the time from the first administration of study treatment to death from any cause.
Time frame: 24 months
Adverse event
rate of adverse events
Time frame: 24 months
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Jiangsu Province Hospital
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...and 9 more locations