Objective of this study to evaluate 1-year disease-free survival in patients with dMMR/MSI-H or POLE/POLD1 gene mutations with gastric or esophagus-gastric junctional adenocarcinoma or colorectal adenocarcinoma after chemotherapy-sequential tiralizumab adjuvant radical resection (based on RECIST v1.1 criteria).
Liver function： Serum albumin≥28g/L; Total bilirubin (TBI)≤1.5×ULN; Alanine aminotransferase (ALT)≤3×ULN Aspartate aminotransferase (AST)≤2.5×ULN
Cardiac function: Left ventricular ejection fraction (LVEF)≥ 50 10. Fertile female subjects must undergo a urine or serum pregnancy test within 3 days prior to the first dosing (if the urine pregnancy test result is not confirmed negative, a serum pregnancy test is required, depending on the serum pregnancy result), and the result is negative If a fertile female subject has sex with an unsterilized male partner, the subject must use a highly effective contraceptive method since screening and must consent to continued use of the contraceptive method for 120 days after the last administration of the study drug; Whether to stop contraception after this time point should be discussed with the investigator 11.If an unsterilized male subject has sex with a fertile female partner, the subject must use an effective contraceptive method from the beginning of screening until the 120th day after the last dose; Whether to stop contraception after this time point should be discussed with the investigator.
Subjects with other malignancies in the 5 years prior to enrolment do not exclude subjects with other malignancies that have been cured by local treatment, such as basal or skin squamous cell carcinoma superficial bladder cancer cervix or breast carcinoma in situ
Have received non-surgical treatment for gastric/esophagogastric junction/bowel cancer (e.g., radiotherapy, chemotherapy and hormone therapy)
Liver peritoneum or distant metastasis
Inability to take medications orally
Single group
tislelizumab
DrugAbout 30 patients who underwent radical gastrectomy or enterectomy with gastric adenocarcinoma or esophagogastric junction adenocarcinoma with postoperative pathological stage III or intestinal adenocarcinoma with postoperative pathological stage T1-3N2M0 or T4N+M0(American Joint Committee on Cancer,AJCC 8th Edition Cancer Stage) were scheduled to be enrolled after fully informed and signed informed consent Qualified subjects were selected to receive the standard XELOX or SOX regimen selected by the investigators according to the disease and postoperative pathology of the subjects for 4 cycles, followed by the sequential treatment of monotherapy tislelizumab (200mg,Q3W, IV infusion,4 cycles) starting from 4-6 weeks after surgery, with a maximum of 12 weeks Safety assessments such as ECOG physical examination of vital signs and laboratory tests will be performed regularly during treatment
1-year disease-free survival based on RECIST v1.1 criteria (1-year DFS rate)
The 1-year DFS rate was defined as the proportion of all subjects who did not have disease recurrence within 1 year from the start of randomization.
1-year MRD-negative survival assessed based on MRD testing
Proportion of all subjects tested MRD negative at 1 year from randomization.
Disease-free survival (DFS)
DFS is defined as the time from the start of randomization until a subject's disease recurrences or death from any cause, whichever occurs first
overall survival (OS)
OS is defined as the time from randomization to death from any cause
time to local recurrence (TTLR)
TTLR was defined as the time from randomization to local tumor recurrence.
dMMR/MSI-H POLE/POLD1 gene mutation, TMB and its dynamic changes, and the relationship between efficacy and adverse reactions
dMMR/MSI-H POLE/POLD1 gene mutation, TMB and its dynamic changes, and the relationship between efficacy and adverse reactions
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