This is a signle-arm, multi-center, open-lable, phase II study. The objective is to evaluate the effectiveness and safety of tislelizumab + oxaliplatin + capecitabine + PLD in the neoadjuvant treatment of resectable gastric adenocarcinoma.
This single-arm, multicenter, open-label study plan to enroll patients with resectable stage III gastric adenocarcinoma to recieve tislelizumab + oxaliplatin + capecitabine + PLD regimen for 2 or 4 cycles, radical resection will be performed after neoadjuvant therapy. Radiological evaluation will be performed every 2 cycles to evaluate the resectability of tumor. Survival follow-up will be performed after surgery, until patient's withdrawal of informed consent, loss to follow-up or death, whichever comes first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
20mg/m2, day 1, q3w
130 mg/m2, day 1, q3w
1000 mg/m2, days 1-14, q3w
Shanghai General Hospital
Shanghai, China
RECRUITINGPathological complete remission rate
Completely resected tumor specimens and all sampled regional lymph nodes were detected without residual infiltration (ie ypT0 ypN0 in AJCC staging version 8.0)
Time frame: 4-month
Objective response rate
Defined as the proportion of subjects whose best overall response is complete response (CR) and partial response (PR).
Time frame: 3-month
R0 resection rate
Defined as the proportion of patients who have achieved R0 resection. R0 surgery is defined as complete resection of the tumor without visible residual lesions either by naked eyes or under microscope.
Time frame: 4-month
3-year overall survival rate
Overall survival (OS) is defined as the time from the enrollment to death for any cause. The Kaplan-Meier curve of OS will be proformed to calculted the 3-year OS rate.
Time frame: 3-year
Progress-free survival
1\) In patients who underwent radical surgery, the time from enrollment to recurrence or death; 2) in patients who did not undergo radical surgery, the time from enrollment to progression (according to RECIST 1.1) or death determined as disease progression.
Time frame: 3-year
3-year PFS rate
The Kaplan-Meier curve of progress-free survival will be proformed to calculted the 3-year PFS rate.
Time frame: 3-year
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200 mg, day 1, q3w