This study aims to explore the safety and efficacy of Disitamab vedotin combined with Sintilimab in elderly patients with HER2 overexpression Gastric Cancer. This is a single-arm exploratory clinical study. 20 patients with eHER2 overexpression gastric cancer are scheduled to be enrolled. Treatment regimen is Disitamab vedotin 2.5mg/kg and Sintilimab 200mg every 21 days, until disease progression or intolerable adverse reactions or death.
The primary objective of this study was to explore the safety and median PFS of Disitamab vedotin combined with Sintilimab as first-line treatment in elderly patients with HER2 overexpression Gastric Cancer.The secondary objective of this study was to evaluate the ORR, DCR, DOR and OS of Disitamab vedotin combined with Sintilimab as first-line treatment in elderly patients with HER2 overexpression Gastric Cancer.To provide a better treatment plan for elderly patients with Gastric Cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Disitamab Vedotin injection:2.5mg/kg,IV,Q3W Sintilimab injection:200mg,IV, Q3W
PFS (Progression-Free-Survival)
The time from randomization to tumor progression or death.The efficacy of this study was determined according to Recist version 1.1 criteria.
Time frame: 24 months
ORR(Objective Response Rate)
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Time frame: 24 months
DCR(Disease control rate)
The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
Time frame: 24 months
DOR(Duration of response)
DoR was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the PFS censoring time.
Time frame: 24 months
OS (Overall survival time)
The time of death from all causes for all patients from the date of randomization.
Time frame: 24 months
The Adverse Events
AEs are any adverse medical events that occur in a subject or clinical subject and is not necessarily causally related to the treatment. Safety assessment in this study was conducted by the investigator in accordance with the definition of CTCAE 5.0.
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.