This study was a single-arm, open, multi-center Phase Ib/II clinical trial to observe and evaluate the efficacy and safety of RC48-ADC plus S-1 in first-line treatment of advanced gastroesophageal adenocarcinoma with moderate expression of HER2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Beijing Friendship Hospital
Beijing, China
RECRUITINGChinese PLA General Hospital
Beijing, China
RECRUITINGChinese PLA General Hospital
Beijing, China
RECRUITINGdose-limiting toxity
Time frame: through study completion, an average of 1 year
ORR(Objective Response Rate)
The proportion of patients whose tumors shrink by a certain amount and remain so for a certain amount of time, including CR+PR cases.
Time frame: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 8 weeks (±7 days) after 1 year
PFS(progression-free survival)
Time from randomness to the first occurrence of disease progression or death from any cause.
Time frame: Imaging tests were performed every 8 weeks (±7 days) from the first year of treatment to assess efficacy, and every 7 weeks (±7 days) after 1 year
DOR(Duration of Response )
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Time frame: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 8 weeks (±7 days) after 1 year
OS(Overall Survival)
Time from randomization to death from any cause
Time frame: From date of randomization until the date of death from any cause, assessed up to 24 months
AE(Adverse Event)
The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0
Time frame: Up to 2 years
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