The purpose of this study is to evaluate the efficacy and safety of sintilimab+ IBI310 for EBV-Positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Arms 1: Neoadjuvant therapy group 20 patients Drug: Sintilimab Weight\<60Kg: 3mg/kg Q3W Weight\>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention:Perioperative Sintilimab+IBI310 are administered for 1-3 (6-18 weeks) cycles followed by 4 postoperative cycles (12 weeks) with Sintilimab monotherapy . Arms 2: first-line therapy group, 30 patients Drug: Sintilimab Weight\<60Kg: 3mg/kg Q3W Weight\>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention:Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years. Arms 3: ≥second-line therapy group, 30 patients Drug: Sintilimab Weight\<60Kg: 3mg/kg Q3W Weight\>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention:Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years.
Arms 1: Neoadjuvant therapy group, 20 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention:Perioperative Sintilimab+ IBI310 are administered for 1-3 (6-18 weeks) cycles followed by 4 postoperative cycles (12 weeks) with Sintilimab monotherapy . Arms 2: first-line therapy group, 30 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention:Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years. Arms 3: ≥second-line therapy group, 30 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention:Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGArms 1: Neoadjuvant therapy group
Pathological complete regression (pCR): Pathological complete regression (pCR) is defined as the proportion of patients with pathological complete regression (TRG1a) over the total number of patients evaluated centrally by the study pathologist
Time frame: Approximately 40 months after the first participant is randomized
Arms 2: first-line therapy group
Objective response rate(ORR): Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group.
Time frame: Approximately 40 months after the first participant is randomized
Arms 3:≥second-line therapy group
Objective response rate(ORR): Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group.
Time frame: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
R0 resection rate
Time frame: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Event free survival(EFS)
Time frame: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Objective response rate(ORR)
Time frame: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Disease control rate(DCR)
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Time frame: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Overall survival(OS)
Time frame: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Number of participants experiencing clinical and laboratory adverse events (AEs).
Time frame: Approximately 40 months after the first participant is randomized
Arms 2: first-line therapy group
Progression-free survival (PFS)
Time frame: Approximately 40 months after the first participant is randomized
Arms 2: first-line therapy group
Disease control rate (DCR)
Time frame: Approximately 40 months after the first participant is randomized
Arms 2: first-line therapy group
Overall survival (OS)
Time frame: Approximately 40 months after the first participant is randomized
Arms 2: first-line therapy group
( Number of participants experiencing clinical and laboratory adverse events (AEs).
Time frame: Approximately 40 months after the first participant is randomized
Arms 3:≥second-line therapy group
Progression-free survival (PFS)
Time frame: Approximately 40 months after the first participant is randomized
Arms 3:≥second-line therapy group
Disease control rate (DCR)
Time frame: Approximately 40 months after the first participant is randomized
Arms 3:≥second-line therapy group
Overall survival (OS)
Time frame: Approximately 40 months after the first participant is randomized
Arms 3:≥second-line therapy group
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time frame: Approximately 40 months after the first participant is randomized