The efficacy and safety of combination with Cadonilimab and CapeOX Regimen for neoadjuvant treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.
This study was a single arm, open-label, single-center clinical study to evaluate the efficacy and safety of combination with Cadonilimab and CapeOX Regimen for neoadjuvant treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Preoperative treatment:130mg/m2,iv, 2h,d1,Q3W; Postoperative treatment:130mg/m2,iv, 2h,d1,Q3W;
Preoperative treatment:1000 mg /m2, PO,bid d1-14,Q3W; Postoperative treatment:1000 mg /m2, PO,bid. d1-14,Q3W;
Cadonilimab 10 mg/kg, d1, Q3W
Xuewei Ding
Tianjin, Tianjin Municipality, China
Pathologic complete remission rate (PCR)
Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.
Time frame: up to 1 years
3-year disease-free survival rate of 3year (DFS)
3 years disease-free survival (DFS) rate is defined as proportion of participants who have no recurrence or metastasis after 3 years of radical treatment
Time frame: up to 3 years
Major pathological response rate (MPR)
Major pathological response (MPR) rate is defined as the proportion of participants whose percentage of residual tumor in the stomach and lymph node decreased to \< 10%, as determined by a pathologist
Time frame: up to 1 years
Objective response rate(ORR)
Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR
Time frame: up to 3 years
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR#PR or SD
Time frame: up to 3 years
Adverse Events(AEs)
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Time frame: up to 3 years
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