About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- tislelizumab