This is a multicenter, phase 2, open label study to evaluate safety, tolerability and efficacy of SHR2554 combined with other anti-tumor treatments in patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
351
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGIncidence and severity of adverse events (AEs).
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: Up to approximately 2 years.
Incidence and severity of serious adverse events (SAEs).
Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: Up to approximately 2 years.
Incidence of Dose Limited Toxicity (DLT).
Time frame: Up to Day 21.
Objective response rate (ORR) by the investigator assessment.
Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator.
Time frame: Up to approximately 1 year.
Duration of objective tumor response (DoR).
Time frame: Approximately 24 months.
Disease control rate (DCR).
Time frame: Approximately 24 months.
Progression-free survival (PFS).
Time frame: Approximately 24 months.
Overall survival (OS) assessed by the investigator.
Time frame: Approximately 24 months.
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SHR-1701 injection