This is a phase 1b study designed to evaluate the safety, tolerability and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) in first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
IBI363 Q3W Oxaliplatin 130 mg/m2,IV,Q3W, Capecitabine ,1000mg/ m2,PO,Bid,d1-14,Q3W
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGObjective response rate (ORR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Time frame: Through out the study (up to 2 years)
Disease control rate (DCR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Time frame: Through out the study (up to 2 years)
Progression Free Survival(PFS);
The efficacy of solid tumors was evaluated according to RECIST v1.1
Time frame: Up to 2 years
Overall Survival, OS)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Time frame: Up to 2 years
Adverse Enent (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.
Time frame: Up to 90 days after the last administration
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