This study is a prospective, single arm, multi-center phase II clinical trial. The primary
study objective is to evaluate the safety of tegafur gimeracil oteracil potassium capsule
plus oxaliplatin and Camrelizumab as adjuvant therapy in stage III gastric cancer, including
the incidences and types of adverse events. The secondary study objective is to observe and
evaluate the disease-free survival (DFS), overall survival (OS) and treatment completion
Study population: participants with stage III gastric cancer confirmed by postoperative
pathology according to American Joint Committee on Cancer (AJCC) / Union for
International Cancer Control (UICC) 8th Tumor Node Metastasis (TNM) staging
Sample size: single arm design was used in this study and 52 participants were estimated
to be enrolled.
Research content: In this study, within 4-6 weeks after the completion of the operation,
the participants were selected and qualified for this study, and were scheduled to
receive 200mg camrelizumab once intravenous infusion on the first day (q3w), then
130mg/m^2 oxaliplatin on the first day (q3w), and tegafur gimeracil oteracil potassium
capsule was taken as follow: surface area is less than 1.25, 80mg per day, twice a day;
≥1.25 ~ <1.5, 100mg per day, twice a day; ≥1.5, 120mg per day, twice a day, and oral
administration for 1-14 days every 3 weeks. Three weeks as a course of treatment, a
total of 8 courses, after treatment, safety visit and survival follow-up will be carried
out. A total of 3 years follow-up time is scheduled since the first medication, and the
frequency is once every 3-6 months within 2 years, and once every 6-12 months for the
Adverse events (AEs) management: To minimize the risk of AEs, the investigators will
monitor carefully to determine whether or not they are within the expected range. The
degree of AEs is evaluated according to The National Cancer Institute Common Terminology
Criteria for Adverse Events (NCI-CTCAE v 4.0). Investigators will also conduct a
thorough examination and adopt an appropriate system to take any necessary measures to
deal with AEs.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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